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A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants (SPAN)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VH3810109
rHuPH20
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring VH3810109, GSK3810109, HIV, Human Monoclonal Antibody, rHuPH20, Pharmacokinetics, Safety, Tolerability, N6LS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the exclusion criteria.
  • Participants having body weight of ≥50 kilogram (kg) and <100 kg
  • Participants having a clinical laboratory profile within the normal range or must have results that do not show clinically significant abnormalities, as judged by the investigator at screening.
  • Contraceptive use by men or women participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Participants who are female at birth are eligible to participate if at least one of the following conditions applies:

Not pregnant or breastfeeding and at least one of the following conditions applies:

Is not a participant of childbearing potential (POCBP) or Is a POCBP and agree to use an acceptable contraceptive method as described in Section 10.4 from 3 weeks prior to the start of this study and during the study. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.

A POCBP must have a negative highly sensitive serum pregnancy test on Day -1, prior to the first dose of study intervention All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom).

The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.

  • Capable of giving written informed consent.

Exclusion Criteria:

  • Hypertension that is not well controlled.
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
  • Positive human immunodeficiency virus (HIV) antibody test.
  • Positive test result for SARS-CoV-2.
  • Evidence of hepatitis B (HB) virus infection at screening or within 3 months prior to first dose of study intervention Participants positive for Hepatitis B antigen (HBsAg) are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for Hepatitis B virus (HBV) DNA are excluded
  • Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
  • The participant has an underlying skin disease or disorder (i.e., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) or tattoos that would interfere with assessment of injection sites.
  • History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A, dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
  • Exposure to an experimental drug, human blood product, or vaccine (which does not have emergency, conditional, or standard market authorization) within 28 days prior to the first dose of study treatment OR plans to receive live vaccines during the study.
  • Prior receipt of licensed or investigational Monoclonal antibody (Mab).
  • Receipt of any investigational study agent within 28 days prior to first dose of study treatment
  • Prior exposure to VH3810109 or rHuPH20 in this or another clinical study.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.
  • Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
  • ALT ≥1.5 times the upper limit of normal (ULN).
  • Total bilirubin ≥1.5 times the ULN (isolated total bilirubin >1.5×ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%).
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Corrected QT interval Fridericia's formula (QTcF)>450 millisecond (msec) for males and QTcF >470 msec for females.
  • The participant has a tattoo or other dermatological condition overlying potential injection sites that may interfere with interpretation of ISRs or administration of VH3810109.
  • Grade 4 laboratory abnormalities.
  • Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
  • Known hypersensitivity to hyaluronidase or any of the excipients in ENHANZE™ Drug Product (EDP)

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: VH3810109 + rHuPH20

Part 2: VH3810109

Arm Description

Healthy participants will receive a single SC dose of VH3810109 injection with rHuPH20.

Healthy participants will receive a single IV dose of VH3810109 injection.

Outcomes

Primary Outcome Measures

Percentage of participants with ≥ Grade 2 adverse events (AEs) following SC administration of VH3810109
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE will be used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms.
Percentage of participants with ≥ Grade 2 AEs following IV administration of VH3810109
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE will be used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms.
Percentage of participants with serious adverse events (SAE) following VH3810109 SC administration
SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician.
Percentage of participants with SAE following VH3810109 IV administration
SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician.
Percentage of participants with injection site reactions (ISRs) following VH3810109 SC administration
ISRs will be recorded via ISR diaries and managed through investigator assessment. Percentage of participants who experience any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) will be reported.
Percentage of participants with ISRs following VH3810109 IV administration
ISRs will be recorded via ISR diaries and managed through investigator assessment. Number of participants who experienced any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) will be reported.
Percentage of participants with Grade 2 to 4 elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) values following VH3810109 SC administration
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
Percentage of participants with Grade 2 to 4 elevated ALT/AST values following VH3810109 IV administration
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.

Secondary Outcome Measures

Part 1 and Part 2: Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC[0-inf]) of VH3810109
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Part 1 and Part 2: AUC from time zero to time t (AUC[0-t]) of VH3810109
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Part 1 and Part 2: Maximum observed concentration (Cmax) of VH3810109
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Part 1 and Part 2: Time of maximum observed concentration (Tmax) of VH3810109
Blood samples will be collected at the indicated time points for pharmacokinetic analysis of VH3810109
Part 1 and Part 2: Apparent terminal phase half-life (t1/2) of VH3810109
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Number of participants with change in dimension score "acceptance of ISRs" using Perception of Injection (PIN) Questionnaire
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.
Number of participants with Individual item score assessing pain using PIN Questionnaire
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. These items in the scale are rated on a 5-point scale ranging from 1(very dissatisfied, extremely, etc.) to 5 (very satisfied, not at all, etc.). Lower scores represent worse perception of injection.
Percentage of participants reporting being bothered or affected by the pain and local reactions based on the PIN Questionnaire
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable.
Percentage of participants with post-injection pain assessment using Numeric Rating Scale (NRS) following VH3810109 SC administration
Post-injection assessment of score will be measured based on NRS which is a 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain).
Percentage of participants with post-injection pain assessment using NRS following VH3810109 IV administration
Post-injection assessment of score will be measured based on NRS which is a 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain).
Percentage of participants reporting ISRs overall and by grade
ISRs will be recorded via ISR diaries and managed through investigator assessment. Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity is categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated. Higher grade indicates more severe condition.
Duration of ISRs overall and by grade
ISRs will be recorded via ISR diaries and managed through investigator assessment.
Change from baseline in Platelets, WBC count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils (cells per microliter)
Change from baseline in Hematocrit (percentage)
Change from baseline in Hgb, albumin and total protein (grams per deciliter)
Change from baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Change from baseline in Mean Corpuscle Volume (MCV) (cubic microns)
Change from baseline in Mean Corpuscle Hemoglobin (MCH) (picograms per cell)
Change from baseline in differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (percentage)
Change from baseline in Glucose (fasting), BUN, Creatinine, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Change from baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide (milliequivalents per liter)
Change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and alkaline phosphatase (ALP) (International Units per liter)
Change from baseline in urine Specific Gravity (ratio)
Number of participants with presence of Glucose, Protein, Blood, Ketones, Bilirubin, Urobilinogen, Nitrite, Leukocyte Esterase in urine
Urine samples will be collected to analyse presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine.
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Change from baseline in PR Interval, QRS Interval, QT Interval, and QT Interval corrected for heart rate using Fridericia's formula (QTcF)
Change from baseline in Temperature
Change from baseline in Pulse Rate
Change from baseline in Respiratory Rate
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Full Information

First Posted
February 16, 2022
Last Updated
May 9, 2023
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05291520
Brief Title
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
Acronym
SPAN
Official Title
A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
VH3810109, GSK3810109, HIV, Human Monoclonal Antibody, rHuPH20, Pharmacokinetics, Safety, Tolerability, N6LS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20
Masking
None (Open Label)
Masking Description
This will be an open-label study. Hence, there will be no masking.
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: VH3810109 + rHuPH20
Arm Type
Experimental
Arm Description
Healthy participants will receive a single SC dose of VH3810109 injection with rHuPH20.
Arm Title
Part 2: VH3810109
Arm Type
Experimental
Arm Description
Healthy participants will receive a single IV dose of VH3810109 injection.
Intervention Type
Biological
Intervention Name(s)
VH3810109
Intervention Description
VH3810109 will be administered.
Intervention Type
Biological
Intervention Name(s)
rHuPH20
Intervention Description
rHuPH20 will be administered.
Primary Outcome Measure Information:
Title
Percentage of participants with ≥ Grade 2 adverse events (AEs) following SC administration of VH3810109
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE will be used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms.
Time Frame
Up to Week 24
Title
Percentage of participants with ≥ Grade 2 AEs following IV administration of VH3810109
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE will be used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms.
Time Frame
Up to Week 24
Title
Percentage of participants with serious adverse events (SAE) following VH3810109 SC administration
Description
SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician.
Time Frame
Up to Week 24
Title
Percentage of participants with SAE following VH3810109 IV administration
Description
SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician.
Time Frame
Up to Week 24
Title
Percentage of participants with injection site reactions (ISRs) following VH3810109 SC administration
Description
ISRs will be recorded via ISR diaries and managed through investigator assessment. Percentage of participants who experience any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) will be reported.
Time Frame
Up to 7 days
Title
Percentage of participants with ISRs following VH3810109 IV administration
Description
ISRs will be recorded via ISR diaries and managed through investigator assessment. Number of participants who experienced any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) will be reported.
Time Frame
Up to 7 days
Title
Percentage of participants with Grade 2 to 4 elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) values following VH3810109 SC administration
Description
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
Time Frame
Up to Week 24
Title
Percentage of participants with Grade 2 to 4 elevated ALT/AST values following VH3810109 IV administration
Description
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
Time Frame
Up to Week 24
Secondary Outcome Measure Information:
Title
Part 1 and Part 2: Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC[0-inf]) of VH3810109
Description
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Time Frame
Up to Week 24
Title
Part 1 and Part 2: AUC from time zero to time t (AUC[0-t]) of VH3810109
Description
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Time Frame
Up to Week 24
Title
Part 1 and Part 2: Maximum observed concentration (Cmax) of VH3810109
Description
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Time Frame
Up to Week 24
Title
Part 1 and Part 2: Time of maximum observed concentration (Tmax) of VH3810109
Description
Blood samples will be collected at the indicated time points for pharmacokinetic analysis of VH3810109
Time Frame
Up to Week 24
Title
Part 1 and Part 2: Apparent terminal phase half-life (t1/2) of VH3810109
Description
Blood samples will be collected at the indicated time points for PK analysis of VH3810109
Time Frame
Up to Week 24
Title
Number of participants with change in dimension score "acceptance of ISRs" using Perception of Injection (PIN) Questionnaire
Description
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.
Time Frame
Day 2 and Day 7
Title
Number of participants with Individual item score assessing pain using PIN Questionnaire
Description
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. These items in the scale are rated on a 5-point scale ranging from 1(very dissatisfied, extremely, etc.) to 5 (very satisfied, not at all, etc.). Lower scores represent worse perception of injection.
Time Frame
Day 2 and Day 7
Title
Percentage of participants reporting being bothered or affected by the pain and local reactions based on the PIN Questionnaire
Description
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable.
Time Frame
Day 2 and Day 7
Title
Percentage of participants with post-injection pain assessment using Numeric Rating Scale (NRS) following VH3810109 SC administration
Description
Post-injection assessment of score will be measured based on NRS which is a 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain).
Time Frame
Day 1, 2 and 7
Title
Percentage of participants with post-injection pain assessment using NRS following VH3810109 IV administration
Description
Post-injection assessment of score will be measured based on NRS which is a 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain).
Time Frame
Day 1, 2 and 7
Title
Percentage of participants reporting ISRs overall and by grade
Description
ISRs will be recorded via ISR diaries and managed through investigator assessment. Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity is categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated. Higher grade indicates more severe condition.
Time Frame
Up to Day 14
Title
Duration of ISRs overall and by grade
Description
ISRs will be recorded via ISR diaries and managed through investigator assessment.
Time Frame
Up to Day 14
Title
Change from baseline in Platelets, WBC count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils (cells per microliter)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Hematocrit (percentage)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Hgb, albumin and total protein (grams per deciliter)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Mean Corpuscle Volume (MCV) (cubic microns)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Mean Corpuscle Hemoglobin (MCH) (picograms per cell)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (percentage)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Glucose (fasting), BUN, Creatinine, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide (milliequivalents per liter)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and alkaline phosphatase (ALP) (International Units per liter)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in urine Specific Gravity (ratio)
Time Frame
Baseline (Day -1) to Week 24
Title
Number of participants with presence of Glucose, Protein, Blood, Ketones, Bilirubin, Urobilinogen, Nitrite, Leukocyte Esterase in urine
Description
Urine samples will be collected to analyse presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine.
Time Frame
Baseline (Day -1) to Week 24
Title
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Description
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in PR Interval, QRS Interval, QT Interval, and QT Interval corrected for heart rate using Fridericia's formula (QTcF)
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Temperature
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Pulse Rate
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Respiratory Rate
Time Frame
Baseline (Day -1) to Week 24
Title
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time Frame
Baseline (Day -1) to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the exclusion criteria. Participants having body weight of ≥50 kilogram (kg) and <100 kg Participants having a clinical laboratory profile within the normal range or must have results that do not show clinically significant abnormalities, as judged by the investigator at screening. Contraceptive use by men or women participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants who are female at birth are eligible to participate if at least one of the following conditions applies: Not pregnant or breastfeeding and at least one of the following conditions applies: Is not a participant of childbearing potential (POCBP) or Is a POCBP and agree to use an acceptable contraceptive method as described in Section 10.4 from 3 weeks prior to the start of this study and during the study. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A POCBP must have a negative highly sensitive serum pregnancy test on Day -1, prior to the first dose of study intervention All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom). The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a POCBP with an early undetected pregnancy. Capable of giving written informed consent. Exclusion Criteria: Hypertension that is not well controlled. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. Positive human immunodeficiency virus (HIV) antibody test. Positive test result for SARS-CoV-2. Evidence of hepatitis B (HB) virus infection at screening or within 3 months prior to first dose of study intervention Participants positive for Hepatitis B antigen (HBsAg) are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for Hepatitis B virus (HBV) DNA are excluded Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study. The participant has an underlying skin disease or disorder (i.e., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) or tattoos that would interfere with assessment of injection sites. History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A, dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). Exposure to an experimental drug, human blood product, or vaccine (which does not have emergency, conditional, or standard market authorization) within 28 days prior to the first dose of study treatment OR plans to receive live vaccines during the study. Prior receipt of licensed or investigational Monoclonal antibody (Mab). Receipt of any investigational study agent within 28 days prior to first dose of study treatment Prior exposure to VH3810109 or rHuPH20 in this or another clinical study. Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. ALT ≥1.5 times the upper limit of normal (ULN). Total bilirubin ≥1.5 times the ULN (isolated total bilirubin >1.5×ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%). Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Corrected QT interval Fridericia's formula (QTcF)>450 millisecond (msec) for males and QTcF >470 msec for females. The participant has a tattoo or other dermatological condition overlying potential injection sites that may interfere with interpretation of ISRs or administration of VH3810109. Grade 4 laboratory abnormalities. Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer. Known hypersensitivity to hyaluronidase or any of the excipients in ENHANZE™ Drug Product (EDP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

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