Dataset from A Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dose and Multiple Doses of GSK3389404 in Chronic Hepatitis B Subjects

GSK3389404 is being developed for the treatment of CHB virus infection. The development goal
for GSK3389404 is the establishment of a finite duration treatment that results in sustained
suppression of hepatitis B virus (HBV) replication and viral antigen production after
cessation of all treatments for CHB due to the restoration of a functional immune response in
the absence of high antigen levels. This study is a multicenter, randomized double-Blind
(sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety,
tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish
proof-of-mechanism. The study will be conducted in two parts. Part 1 plans to enroll subjects
primarily from the Asia-pacific region, including Japan and will be conducted as a single
ascending dose (SAD) study with 5 planned cohorts ranging from 30 milligram (mg) to a maximum
of 240 mg GSK3389404. Within each cohort, subjects will be randomized to receive either
GSK3389404 or placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in a
sequential fashion; Cohort C1 is an optional cohort and may be dosed after Cohort C or in
parallel with Cohort D. Part 2 will be conducted as a multiple-dose, dose-ranging study.
Subjects will be randomized to different parallel dose levels and regimens or placebo. The
dose levels of Part 2 will be selected after a review of Part 1 safety, Pharmacokinetic (PK)
and Pharmacodynamic (PD) data. The treatments selected are 60 mg GSK3389404 weekly, 120 mg
GSK3389404 bi-weekly, 120 mg GSK3389404 weekly or placebo. An optional Japanese part-2
sub-study is planned. The total study duration for part 1 including screening, treatment, and
post-treatment follow-up, will not be expected to exceed 13 weeks for each subject and for
part 2, including screening, treatment and post-treatment follow-up, will not be expected to
exceed 65 weeks for each subject.