Stopped: The study was terminated as a strategic decision
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy participants. Part 3 will evaluate the ability of GSK3965193 to lower hepatitis B virus surface antigen (HBsAg) in participants living with chronic hepatitis B infection (PLWCHB) and will be given the option to subsequently receive treatment with open label bepirovirsen. Part 4 will evaluate the safety and tolerability of combination therapy with GSK3965193 and bepirovirsen and the potential to effect sustained virologic response in PLWCHB.
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Treatment Emergent Adverse Events (STEAEs), and Treatment Withdrawals Due to TEAEs
Timeframe: From the start of study intervention (Day 1) up to 12 weeks
Part 2A: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Timeframe: From the start of study intervention (Day 1) up to 6 weeks
Part 2B: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Timeframe: From the start of study intervention (Day 1) up to 9 weeks
Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Timeframe: From the start of study intervention (Day 1) up to 6 weeks
Part 4: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Timeframe: From the start of study intervention (Day 1) up to 48 weeks
Part 1: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Timeframe: At Day 2
Part 2A: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Timeframe: Up to 21 days
Part 2B: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Timeframe: Up to 9 weeks
Part 3: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Timeframe: Up to 35 days
Part 3: Number of Participants With Clinically Significant Urinalysis Parameters
Timeframe: Up to 28 days
Part 4: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Timeframe: Up to 48 weeks
Part 1: Number of Participants With Clinically Significant Vital Sign Findings
Timeframe: Up to 12 weeks
Part 2A: Number of Participants With Clinically Significant Vital Sign Findings
Timeframe: Up to 21 days
Part 2B: Number of Participants With Clinically Significant Vital Sign Findings
Timeframe: Up to 9 weeks
Part 3: Number of Participants With Clinically Significant Vital Sign Findings
Timeframe: Up to 35 days
Part 4: Number of Participants With Clinically Significant Vital Signs Findings
Timeframe: Up to 48 weeks
Part 1: Number of Participants With Clinically Significant Electrocardiogram [ECG] Findings
Timeframe: Up to 12 weeks
Part 2A: Number of Participants With Clinically Significant ECG Findings
Timeframe: Up to 21 days
Part 3: Number of Participants With Clinically Significant ECG Findings
Timeframe: Up to 35 days
Part 4: Number of Participants With Clinically Significant ECG Findings
Timeframe: Up to 25 weeks
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 7
Timeframe: Baseline and Day 7
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 14
Timeframe: Baseline and Day 14
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 42
Timeframe: Baseline and Day 42
Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 15
Timeframe: Baseline and Day 15
Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 29
Timeframe: Baseline and Day 29
Part 4: Number of Participants With Changes in Sensory Nerve Conduction
Timeframe: Baseline up to 29 days
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3965193 Following Single Dose Administration
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours (h) post-dose
Part 2A: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3965193 Following Repeat Dose Administration
Timeframe: Pre-dose and 15 minutes (min), 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, and 12 h post-first dose on Day 14
Part 1: Maximum Observed Concentration (Cmax) of GSK3965193 Following Single Dose Administration
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Part 2A: Cmax of GSK3965193 Following Repeat Dose Administration
Timeframe: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3965193 Following Single Dose Administration
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Part 2A: Tmax of GSK3965193 Following Repeat Dose Administration
Timeframe: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Part 1: Apparent Terminal Half-life (T1/2) of GSK3965193 Following Single Dose Administration
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Part 2A: T1/2 of GSK3965193 Following Repeat Dose Administration
Timeframe: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Part 3: Maximum Reduction of Serum HBsAg Levels From Baseline
Timeframe: From Baseline (Pre-dose on Day 1) up to 6 weeks
Part 4: Number of Participants Achieving Complete Response
Timeframe: Up to 48 weeks