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A Phase 1 Study of AV-380 in Healthy Subjects

Primary Purpose

Cachexia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AV-380
Placebo
Sponsored by
AVEO Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy male and female volunteers, 18 to 50 years of age, inclusive.
  2. A body mass index (BMI) between 18 and 30 kg/m2 and weight between 60 and 90 kg.
  3. Healthy as indicated by a comprehensive clinical assessment (detailed medical history and complete physical examination). Supine blood pressure (BP), heart rate (HR), electrocardiogram (ECG) intervals and routine laboratory tests within the normal range of the study center (see Appendix 4) or considered not clinically significant by the Investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin must be < 1.5 times the upper limit of the normal range (ULN). Total bilirubin, if above 1.5 x ULN, is only acceptable with a history of Gilbert's Syndrome.
  4. Non-smoker or ex-smoker for longer than 6 months.
  5. Sexually active pre-menopausal female subjects and female partners of male subjects must use adequate contraceptive measures, while on study and for at least 100 days after the IMP administration. Sexually active male subjects must use adequate contraceptive measures, while on study and for at least 160 days after the last dose of IMP. All fertile male and female subjects and their partners must agree to use a highly effective method of contraception. Effective birth control includes hormonal contraception (oral, intravaginal, transdermal, injectable or implantable), intrauterine device (IUD) plus one barrier method; or 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). Vasectomy (at least 3 months before IMP administration) and vasectomized partner (provided that the partner is the sole sexual partner of the trial participant and that the absence of sperm in the ejaculate has been confirmed) are acceptable methods of contraception, as well as post-menopausal female for at least 1 year (confirmed with serum follicle stimulating hormone [FSH] > 25.8 IU/L at screening), or surgically sterilized female subjects. Abstinence is not an acceptable contraception method. Female subjects who are of non-childbearing potential due to a surgical procedure or medical condition must provide documentation, and vasectomized male subjects must bring in the surgical report of the procedure.
  6. Able to sign and understand an ICF and able to comply with study restrictions prior to selection.

Exclusion Criteria:

  1. Presence or history of any disorder that may prevent the successful completion of the study.
  2. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), such as:

    • White blood cell count < 3.0x109/L.
    • Neutrophils < 1.5x109/L or clinically abnormal according to the subject's ethnic group (must be > 1.0x109/L for subjects of African descent).
    • Hemoglobin < 10 g/dL.
    • Platelet count < 125x109/L or > 450x109/L.
    • ALT > 1.5 ULN.
    • AST > 1.5 ULN.
    • Total bilirubin > 1.5 ULN (except in the presence of Gilbert's syndrome).
    • Creatinine > 1.2 ULN.
    • Sodium < 132 mmol/L or > 147 mmol/L.
    • Potassium < 3.2 mmol/L or > 5.5 mmol/L.
    • Chloride < 93 mmol/L or > 111 mmol/L.
    • Calcium < 8.3 mmol/L or > 10.7 mmol/L. Clinically significant abnormal values for all other laboratory parameters are at the investigator's discretion.
  3. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational medicine product.
  4. Any history of drug related hypersensitivity reaction.
  5. Prior treatment with a monoclonal antibody.
  6. Intercurrent illness as evidenced by, e.g., nausea, vomiting, fever, or diarrhea) within 7 days before D1.
  7. History of drug abuse (habitual taking of addictive or illegal drugs) within 1 year before D1.
  8. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or grapefruit-containing products or alcoholic beverages within 48 hours before D1 and until D7.
  9. Any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator or his designee.
  10. Frequent headaches and/or migraine, recurrent nausea and / or vomiting.
  11. Female subjects who are pregnant, or breastfeeding.
  12. Positive screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine [PCP]) and breath alcohol test at screening or D-2.
  13. Positive serology for hepatitis B or hepatitis C or human immunodeficiency viruses (HIV).
  14. Positive SARS-CoV-2 RT-PCR.
  15. Any condition detected at screening that may interfere with or bias the physical examinations to be performed during the study.
  16. Any prescribed or over-the-counter medication or herbal products taken within 1 week prior to start of administration of IMP (D1) or within 6 times the elimination half-life of the medication prior to start of IMP intake (whichever is longer), except birth control as described in inclusion criterion number 5 in Section 6.1. Vitamin/mineral supplements and occasional use of acetaminophen is allowed up until 24 hours before dosing.
  17. Participation in a clinical trial or use of an investigational drug within 30 days before randomization.
  18. Any vaccination within 30 days before signature of informed consent.

Sites / Locations

  • Biotrial Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AV-380 IV 4 mg/kg

AV-380 IV 8 mg/kg

AV-380 IV 13 mg/kg

AV-380 IV 20 mg/kg

AV-380 SC 4 mg/kg

AV-380 SC 2 mg/kg

AV-380 SC 1 mg/kg

Placebo

Arm Description

IV infusion of AV-380 at dose level 4 mg/kg

IV infusion of AV-380 at dose level 8 mg/kg

IV infusion of AV-380 at dose level 13 mg/kg

IV infusion of AV-380 at dose level 20 mg/kg

Subcutaneous injection of AV-380 at dose level 4 mg/kg

Subcutaneous injection of AV-380 at dose level 2 mg/kg

Subcutaneous injection of AV-380 at dose level 1 mg/kg

Outcomes

Primary Outcome Measures

Assessment of adverse events (AEs) and treatment emergent adverse events (TEAEs)
Injection site safety and tolerability assessment
Site injection tolerability will be assessed by the Investigator using a 4-level score (none, mild, moderate, severe) after IV infusion and SC injection.
Clinical laboratory measurements - Hematology - hemoglobin
Hemoglobin (g/dL)
Clinical laboratory measurements - Hematology - hematocrit
Hematocrit (%)
Clinical laboratory measurements - Hematology - erythrocytes
Erythrocytes
Clinical laboratory measurements - Hematology - white blood cell count
White blood cell count with differential (neutrophils, basophils, eosinophils, lymphocytes, monocytes and platelets) (X10(3)/UL)
Clinical laboratory measurements - Blood chemistry - sodium
Sodium (mmol/L)
Clinical laboratory measurements - Blood chemistry - potassium
Potassium (mmol/L)
Clinical laboratory measurements - Blood chemistry - calcium
Calcium (mg/dL)
Clinical laboratory measurements - Blood chemistry - chloride
Chloride (mmol/L)
Clinical laboratory measurements - Blood chemistry - CO2
CO2 (mmol/L)
Clinical laboratory measurements - Blood chemistry - blood urea nitrogen
Blood urea nitrogen (mg/dl)
Clinical laboratory measurements - Blood chemistry - creatinine
creatinine (mg/dL), glucose, total proteins, triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Clinical laboratory measurements - Blood chemistry - glucose
Glucose (mg/dL)
Clinical laboratory measurements - Blood chemistry - total proteins
Total proteins (g/dL), triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Clinical laboratory measurements - Blood chemistry - triglycerides
Triglycerides (mg/dL)
Clinical laboratory measurements - Blood chemistry - total cholesterol
Total cholesterol (mg/dL)
Clinical laboratory measurements - Blood chemistry - AST
AST (U/L)
Clinical laboratory measurements - Blood chemistry - ALT
ALT (U/L)
Clinical laboratory measurements - Blood chemistry - Gamma-glutamyltransferase
Gamma-glutamyltransferase (U/L)
Clinical laboratory measurements - Blood chemistry - Creatinine phosphokinase
Creatinine phosphokinase (mg/dL)
Clinical laboratory measurements - Blood chemistry - albumin
Albumin (g/dL)
Clinical laboratory measurements - Blood chemistry - alkaline phosphatase
Alkaline phosphatase (U/L)
Clinical laboratory measurements - Blood chemistry - total bilirubin
Total bilirubin (mg/dl)
Clinical laboratory measurements - Coagulation - partial thromboplastin time
Activated partial thromboplastin time (secs)
Clinical laboratory measurements - Coagulation - prothrombin time
Prothrombin time (sec)
Clinical laboratory measurements - Coagulation - International normalized ratio
International normalized ratio
Clinical laboratory measurements - Hormonology
Measured parameters: Hormonology (TSH, FSH (for post-menopausal women); β-HCG (for women of childbearing potential))
Clinical laboratory measurements - Hormonology - TSH
TSH (mIU/mL)
Clinical laboratory measurements - Hormonology - FSH
FSH (mIU/mL)
Clinical laboratory measurements - Urinalysis - pH
pH
Clinical laboratory measurements - Urinalysis - protein
Protein (negative/positive)
Clinical laboratory measurements - Urinalysis - glucose
Glucose (negative/positive)
Clinical laboratory measurements - Urinalysis - leukocytes
Leukocytes (negative/positive)
Clinical laboratory measurements - Urinalysis - nitrites
Nitrites (negative/positive)
Clinical laboratory measurements - Urinalysis - ketones
Ketones (negative/positive)
Clinical laboratory measurements - Urinalysis - blood
Blood (negative/positive)
Vital signs measurements - Blood pressure
Supine and standing systolic and diastolic blood pressure (mmHg)
Vital signs measurements - Heart rate
Heart rate (beats/min)
Vital signs measurements - Body temperature
Body temperature (degrees Celsius)
Vital signs measurements - Respiratory rate
Respiratory rate (breaths/min)
Electrocardiogram (ECG) measurements - Mean heart rate
ECG mean heart rate (beats/min)
Electrocardiogram (ECG) measurements - PR interval
PR interval, aggregate (msec)
Electrocardiogram (ECG) measurements - QRS axis
QRS axis (deg)
Electrocardiogram (ECG) measurements - QTcF interval
QTcF interval, aggregate (msec)

Secondary Outcome Measures

Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Cmax (maximum observed serum concentration)
Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Tmax (time to reach maximum serum concentration)
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Emax (maximum effect observed)
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
AUEC (area under the effect-time curve)
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
TEmax (time to reach maximum effect)
AV-380 immunogenicity in healthy subjects - anti-AV-380 antibodies (human anti-human antibodies [HAHA]) levels in serum.
HAHA levels
AV-380 immunogenicity in healthy subjects - Monocyte chemoattractant protein 1 (MCP-1) levels in serum.
Serum MCP-1 levels will be measured.

Full Information

First Posted
March 8, 2021
Last Updated
June 8, 2023
Sponsor
AVEO Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04815551
Brief Title
A Phase 1 Study of AV-380 in Healthy Subjects
Official Title
A Phase 1, First-in-human, Randomized, Placebo Controlled, Double Blind, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AV-380 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AVEO Pharmaceuticals, Inc.

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
This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AV-380 IV 4 mg/kg
Arm Type
Experimental
Arm Description
IV infusion of AV-380 at dose level 4 mg/kg
Arm Title
AV-380 IV 8 mg/kg
Arm Type
Experimental
Arm Description
IV infusion of AV-380 at dose level 8 mg/kg
Arm Title
AV-380 IV 13 mg/kg
Arm Type
Experimental
Arm Description
IV infusion of AV-380 at dose level 13 mg/kg
Arm Title
AV-380 IV 20 mg/kg
Arm Type
Experimental
Arm Description
IV infusion of AV-380 at dose level 20 mg/kg
Arm Title
AV-380 SC 4 mg/kg
Arm Type
Experimental
Arm Description
Subcutaneous injection of AV-380 at dose level 4 mg/kg
Arm Title
AV-380 SC 2 mg/kg
Arm Type
Experimental
Arm Description
Subcutaneous injection of AV-380 at dose level 2 mg/kg
Arm Title
AV-380 SC 1 mg/kg
Arm Type
Experimental
Arm Description
Subcutaneous injection of AV-380 at dose level 1 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AV-380
Intervention Description
AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is sterile liquid for IV infusion.
Primary Outcome Measure Information:
Title
Assessment of adverse events (AEs) and treatment emergent adverse events (TEAEs)
Time Frame
Through study completion, an average of 60 days
Title
Injection site safety and tolerability assessment
Description
Site injection tolerability will be assessed by the Investigator using a 4-level score (none, mild, moderate, severe) after IV infusion and SC injection.
Time Frame
Visit Day 1
Title
Clinical laboratory measurements - Hematology - hemoglobin
Description
Hemoglobin (g/dL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Hematology - hematocrit
Description
Hematocrit (%)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Hematology - erythrocytes
Description
Erythrocytes
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Hematology - white blood cell count
Description
White blood cell count with differential (neutrophils, basophils, eosinophils, lymphocytes, monocytes and platelets) (X10(3)/UL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - sodium
Description
Sodium (mmol/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - potassium
Description
Potassium (mmol/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - calcium
Description
Calcium (mg/dL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - chloride
Description
Chloride (mmol/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - CO2
Description
CO2 (mmol/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - blood urea nitrogen
Description
Blood urea nitrogen (mg/dl)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - creatinine
Description
creatinine (mg/dL), glucose, total proteins, triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - glucose
Description
Glucose (mg/dL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - total proteins
Description
Total proteins (g/dL), triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - triglycerides
Description
Triglycerides (mg/dL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - total cholesterol
Description
Total cholesterol (mg/dL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - AST
Description
AST (U/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - ALT
Description
ALT (U/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - Gamma-glutamyltransferase
Description
Gamma-glutamyltransferase (U/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - Creatinine phosphokinase
Description
Creatinine phosphokinase (mg/dL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - albumin
Description
Albumin (g/dL)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - alkaline phosphatase
Description
Alkaline phosphatase (U/L)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Blood chemistry - total bilirubin
Description
Total bilirubin (mg/dl)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Coagulation - partial thromboplastin time
Description
Activated partial thromboplastin time (secs)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Coagulation - prothrombin time
Description
Prothrombin time (sec)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Coagulation - International normalized ratio
Description
International normalized ratio
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Hormonology
Description
Measured parameters: Hormonology (TSH, FSH (for post-menopausal women); β-HCG (for women of childbearing potential))
Time Frame
Visits Day 1 through Day 90
Title
Clinical laboratory measurements - Hormonology - TSH
Description
TSH (mIU/mL)
Time Frame
Visits Day 1 through Day 90
Title
Clinical laboratory measurements - Hormonology - FSH
Description
FSH (mIU/mL)
Time Frame
Visits Day 1 through Day 90
Title
Clinical laboratory measurements - Urinalysis - pH
Description
pH
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Urinalysis - protein
Description
Protein (negative/positive)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Urinalysis - glucose
Description
Glucose (negative/positive)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Urinalysis - leukocytes
Description
Leukocytes (negative/positive)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Urinalysis - nitrites
Description
Nitrites (negative/positive)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Urinalysis - ketones
Description
Ketones (negative/positive)
Time Frame
Visits Day 1 through Day 60
Title
Clinical laboratory measurements - Urinalysis - blood
Description
Blood (negative/positive)
Time Frame
Visits Day 1 through Day 60
Title
Vital signs measurements - Blood pressure
Description
Supine and standing systolic and diastolic blood pressure (mmHg)
Time Frame
Visits Day 1 through Day 90
Title
Vital signs measurements - Heart rate
Description
Heart rate (beats/min)
Time Frame
Visits Day 1 through Day 90
Title
Vital signs measurements - Body temperature
Description
Body temperature (degrees Celsius)
Time Frame
Visits Day 1 through Day 90
Title
Vital signs measurements - Respiratory rate
Description
Respiratory rate (breaths/min)
Time Frame
Visits Day 1 through Day 90
Title
Electrocardiogram (ECG) measurements - Mean heart rate
Description
ECG mean heart rate (beats/min)
Time Frame
Visits Day 1 through Day 90
Title
Electrocardiogram (ECG) measurements - PR interval
Description
PR interval, aggregate (msec)
Time Frame
Visits Day 1 through Day 90
Title
Electrocardiogram (ECG) measurements - QRS axis
Description
QRS axis (deg)
Time Frame
Visits Day 1 through Day 90
Title
Electrocardiogram (ECG) measurements - QTcF interval
Description
QTcF interval, aggregate (msec)
Time Frame
Visits Day 1 through Day 90
Secondary Outcome Measure Information:
Title
Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Description
Cmax (maximum observed serum concentration)
Time Frame
Visits Day 1 through D90
Title
Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Description
Tmax (time to reach maximum serum concentration)
Time Frame
Visits Day 1 through Day 90
Title
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Description
Emax (maximum effect observed)
Time Frame
Visits Day 1 through Day 90
Title
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Description
AUEC (area under the effect-time curve)
Time Frame
Visits Day 1 through Day 90
Title
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Description
TEmax (time to reach maximum effect)
Time Frame
Visits Day 1 through Day 90
Title
AV-380 immunogenicity in healthy subjects - anti-AV-380 antibodies (human anti-human antibodies [HAHA]) levels in serum.
Description
HAHA levels
Time Frame
Visits Day 1 through Day 180
Title
AV-380 immunogenicity in healthy subjects - Monocyte chemoattractant protein 1 (MCP-1) levels in serum.
Description
Serum MCP-1 levels will be measured.
Time Frame
Visits Day 1 and Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male and female volunteers, 18 to 50 years of age, inclusive. A body mass index (BMI) between 18 and 30 kg/m2 and weight between 60 and 90 kg. Healthy as indicated by a comprehensive clinical assessment (detailed medical history and complete physical examination). Supine blood pressure (BP), heart rate (HR), electrocardiogram (ECG) intervals and routine laboratory tests within the normal range of the study center (see Appendix 4) or considered not clinically significant by the Investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin must be < 1.5 times the upper limit of the normal range (ULN). Total bilirubin, if above 1.5 x ULN, is only acceptable with a history of Gilbert's Syndrome. Non-smoker or ex-smoker for longer than 6 months. Sexually active pre-menopausal female subjects and female partners of male subjects must use adequate contraceptive measures, while on study and for at least 100 days after the IMP administration. Sexually active male subjects must use adequate contraceptive measures, while on study and for at least 160 days after the last dose of IMP. All fertile male and female subjects and their partners must agree to use a highly effective method of contraception. Effective birth control includes hormonal contraception (oral, intravaginal, transdermal, injectable or implantable), intrauterine device (IUD) plus one barrier method; or 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). Vasectomy (at least 3 months before IMP administration) and vasectomized partner (provided that the partner is the sole sexual partner of the trial participant and that the absence of sperm in the ejaculate has been confirmed) are acceptable methods of contraception, as well as post-menopausal female for at least 1 year (confirmed with serum follicle stimulating hormone [FSH] > 25.8 IU/L at screening), or surgically sterilized female subjects. Abstinence is not an acceptable contraception method. Female subjects who are of non-childbearing potential due to a surgical procedure or medical condition must provide documentation, and vasectomized male subjects must bring in the surgical report of the procedure. Able to sign and understand an ICF and able to comply with study restrictions prior to selection. Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), such as: White blood cell count < 3.0x109/L. Neutrophils < 1.5x109/L or clinically abnormal according to the subject's ethnic group (must be > 1.0x109/L for subjects of African descent). Hemoglobin < 10 g/dL. Platelet count < 125x109/L or > 450x109/L. ALT > 1.5 ULN. AST > 1.5 ULN. Total bilirubin > 1.5 ULN (except in the presence of Gilbert's syndrome). Creatinine > 1.2 ULN. Sodium < 132 mmol/L or > 147 mmol/L. Potassium < 3.2 mmol/L or > 5.5 mmol/L. Chloride < 93 mmol/L or > 111 mmol/L. Calcium < 8.3 mmol/L or > 10.7 mmol/L. Clinically significant abnormal values for all other laboratory parameters are at the investigator's discretion. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational medicine product. Any history of drug related hypersensitivity reaction. Prior treatment with a monoclonal antibody. Intercurrent illness as evidenced by, e.g., nausea, vomiting, fever, or diarrhea) within 7 days before D1. History of drug abuse (habitual taking of addictive or illegal drugs) within 1 year before D1. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or grapefruit-containing products or alcoholic beverages within 48 hours before D1 and until D7. Any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator or his designee. Frequent headaches and/or migraine, recurrent nausea and / or vomiting. Female subjects who are pregnant, or breastfeeding. Positive screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine [PCP]) and breath alcohol test at screening or D-2. Positive serology for hepatitis B or hepatitis C or human immunodeficiency viruses (HIV). Positive SARS-CoV-2 RT-PCR. Any condition detected at screening that may interfere with or bias the physical examinations to be performed during the study. Any prescribed or over-the-counter medication or herbal products taken within 1 week prior to start of administration of IMP (D1) or within 6 times the elimination half-life of the medication prior to start of IMP intake (whichever is longer), except birth control as described in inclusion criterion number 5 in Section 6.1. Vitamin/mineral supplements and occasional use of acetaminophen is allowed up until 24 hours before dosing. Participation in a clinical trial or use of an investigational drug within 30 days before randomization. Any vaccination within 30 days before signature of informed consent.
Facility Information:
Facility Name
Biotrial Inc.
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Phase 1 Study of AV-380 in Healthy Subjects

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