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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06058390

Collaborator

(none)

200

Enrollment

Locations

Arms

8.1

Anticipated Duration (Months)

100

Patients Per Site

12.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Drug: Bepirovirsen	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 26, 2023

Anticipated Primary Completion Date :

May 30, 2024

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).	Drug: Bepirovirsen Bepirovirsen will be administered.
Experimental: Group 2 Participants will receive Bepirovirsen PFS SSD administered by HCP.	Drug: Bepirovirsen Bepirovirsen will be administered.
Experimental: Group 3 Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.	Drug: Bepirovirsen Bepirovirsen will be administered.
Experimental: Group 4 Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.	Drug: Bepirovirsen Bepirovirsen will be administered.

Outcome Measures

Primary Outcome Measures

Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants [Up to Day 64]
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 [Up to Day 64]
Blood samples will be collected at indicated timepoints.

Secondary Outcome Measures

Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 3 Participants [Up to Day 64]
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 [Up to Day 64]
Blood samples will be collected at indicated timepoints.
Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 4 Participants [Up to Day 64]
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 [Up to Day 64]
Blood samples will be collected at indicated timepoints.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.