Full name
Four-part, Randomized, Double-blind (Parts 1, 2A, 3 and 4), Multi-center, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK3965193 Monotherapy in Healthy Participants and in Participants Living With Chronic Hepatitis B Infection; and GSK3965193 in Combination With Bepirovirsen in Participants Living With Chronic Hepatitis B Infection
NCT Number
NCT05330455
Geography
Non-US
Locations
Canada, France, Italy, South Korea, Thailand, United Kingdom
Primary Endpoints
- Parts 1 and 2B: Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs. Up to 14 days
- Part 2A: Number of participants with AEs, SAEs, and withdrawals due to AEs. Up to 42 Days
- Parts 1: Number of participants with clinically significant changes in laboratory parameters. Up to 2 days
- Parts 2B: Number of participants with clinically significant changes in laboratory parameters. Up to 14 days
- Parts 1 and 2B: Number of participants with clinically significant changes in vital signs and cardiac parameters (electrocardiogram [ECG]). Up to 14 days
- Part 2A: Number of participants with clinically significant changes in laboratory parameters, vital signs, cardiac parameters (ECG). Up to 21 days
- Part 2A: Number of participants with clinically significant nerve changes. Up to 42 days
- Part 1 and 2B: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) of GSK3965193 following single dose administration. Up to 4 days
- Part 2A: AUC(0-tau) of GSK3965193 following repeat dose administration. Up to 17 days
- Part 1 and 2B: maximum observed concentration (Cmax) of GSK3965193 following single dose administration. Up to 4 days
- Part 2A: Cmax of GSK3965193 following repeat dose administration. Up to 17 days
- Part 1 and 2B: Time to maximum observed plasma drug concentration (Tmax) of GSK3965193 following single dose administration. Up to 4 days
- Part 2A: Tmax of GSK3965193 following repeat dose administration. Up to 17 days
- Part 1 and 2B: Apparent terminal half-life (T1/2) of GSK3965193 following single dose administration. Up to 4 days
- Part 2A: T1/2 of GSK3965193 following repeat dose administration. Up to 17 days
- Part 3: Number of participants with AEs, SAEs, and withdrawals due to AEs. Up to 42 days
- Part 4: Number of participants with AEs, SAEs, and withdrawals due to AEs. Up to 48 weeks
- Part 3: Number of participants with clinically significant changes in laboratory parameters and vital signs. Up to 42 days
- Part 3: Number of participants with clinically significant changes in cardiac parameters (ECG). Up to 42 days
- Part 4: Number of participants with clinically significant changes in laboratory parameters and vital signs Up to 48 weeks
- Part 4: Number of participants with clinically significant changes in cardiac parameters (ECG). Up to 48 weeks
- Part 3: Number of participants with clinically significant nerve changes. Up to 42 days
- Part 4: Number of participants with clinically significant nerve changes. Up to 48 weeks
- Part 3: Maximum reduction of serum HBsAg levels from Baseline. Baseline and up to 6 weeks
- Part 4: Number of participants achieving complete response. Up to 48 weeks
Order
6
Disease
Version
Phase
1/2a
Status
Active, not recruiting