A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3640254 in Healthy Participants

Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat
throughout the world and development of medicines with new mechanism of action have an
important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in
HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will
collect information on safety, tolerability and drug levels in the body of in healthy
subjects for GSK3640254. The information collected in this study will help in further
clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in
HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single
oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be
randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be
given immediately after a moderate fat meal. Maximum duration of study participation will be
approximately 12 weeks.