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A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants

Primary Purpose

Hepatitis B

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bepirovirsen
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis B, Hepatitis, Viral, Human, Virus Diseases, Bepirovirsen, GSK3228836, 219239, Liver Diseases

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy participants as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECGs) and vital signs. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol. Exclusion Criteria: Past or current medical conditions which, in the judgement of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant. Abnormal blood pressure as determined by the investigator. Positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test results. Participants with signs or symptoms suggestive of Coronavirus disease 2019 (COVID-19) within 14 days of inpatient admission, or with a positive test for active COVID-19 infection before study start. Past, current or intended use of over the counter or prescription medication [including herbal medications] Current or prior use of creatine-containing supplements and intended use up to 50 days post-dosing. Prior use of immunosuppressive drugs within 3 months before dosing or interferon within 12 months before dosing. Prior treatment with any oligonucleotide or small interfering ribonucleoside (RNA) siRNA within 12 months before dosing. Loss of blood or blood products in excess of 500 millilitre (mL) within any 3-month period during the study. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. Current enrolment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 5-half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or within the last 90 days (if half-life and duration of biological effect are unknown), before the first dosing day in the current study. Current enrolment or past participation in this clinical study. Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. Regular alcohol consumption of alcohol within 6 months prior to the study. Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC). History of sensitivity to bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor contraindicates their participation.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).

Participants will receive Bepirovirsen PFS SSD administered by HCP.

Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.

Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.

Outcomes

Primary Outcome Measures

Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Blood samples will be collected at indicated timepoints.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Blood samples will be collected at indicated timepoints.

Secondary Outcome Measures

Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
Blood samples will be collected at indicated timepoints.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
Blood samples will be collected at indicated timepoints.
Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 4 Participants
Blood samples will be collected at indicated timepoints.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 4 Participants
Blood samples will be collected at indicated timepoints.

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT06058390
Brief Title
A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
Official Title
A Phase 1, Randomized, Open-Label, Parallel Group Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 26, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, randomized study to investigate subcutaneous (SC) bepirovirsen when delivered via SC injection from vial or Prefilled syringe fitted with a Safety syringe device (PFS SSD) in healthy adult participants. The aim of this study is to provide relative bioavailability data to support the transition from the vial presentation of bepirovirsen, to a ready-to-use liquid in a PFS SSD when both are given by a health care professional. The study will also assess self-administration using the PFS SDD, and the safety and tolerability of bepirovirsen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B, Hepatitis, Viral, Human, Virus Diseases, Bepirovirsen, GSK3228836, 219239, Liver Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants will receive Bepirovirsen PFS SSD administered by HCP.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.
Intervention Type
Drug
Intervention Name(s)
Bepirovirsen
Intervention Description
Bepirovirsen will be administered.
Primary Outcome Measure Information:
Title
Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Description
Blood samples will be collected at indicated timepoints.
Time Frame
Up to Day 64
Title
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Description
Blood samples will be collected at indicated timepoints.
Time Frame
Up to Day 64
Secondary Outcome Measure Information:
Title
Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
Description
Blood samples will be collected at indicated timepoints.
Time Frame
Up to Day 64
Title
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
Description
Blood samples will be collected at indicated timepoints.
Time Frame
Up to Day 64
Title
Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 4 Participants
Description
Blood samples will be collected at indicated timepoints.
Time Frame
Up to Day 64
Title
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 4 Participants
Description
Blood samples will be collected at indicated timepoints.
Time Frame
Up to Day 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy participants as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECGs) and vital signs. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol. Exclusion Criteria: Past or current medical conditions which, in the judgement of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant. Abnormal blood pressure as determined by the investigator. Positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test results. Participants with signs or symptoms suggestive of Coronavirus disease 2019 (COVID-19) within 14 days of inpatient admission, or with a positive test for active COVID-19 infection before study start. Past, current or intended use of over the counter or prescription medication [including herbal medications] Current or prior use of creatine-containing supplements and intended use up to 50 days post-dosing. Prior use of immunosuppressive drugs within 3 months before dosing or interferon within 12 months before dosing. Prior treatment with any oligonucleotide or small interfering ribonucleoside (RNA) siRNA within 12 months before dosing. Loss of blood or blood products in excess of 500 millilitre (mL) within any 3-month period during the study. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. Current enrolment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 5-half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or within the last 90 days (if half-life and duration of biological effect are unknown), before the first dosing day in the current study. Current enrolment or past participation in this clinical study. Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. Regular alcohol consumption of alcohol within 6 months prior to the study. Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC). History of sensitivity to bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor contraindicates their participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Samuel P Pak
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Brian Spears

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants

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