Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
Status:
Terminated
Trial end date:
2020-03-23
Target enrollment:
Participant gender:
Summary
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled,
FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess
the safety, tolerability, and pharmacokinetic (PK)/pharmacodynamic (PD) attributes of
GSK3732394 in healthy subjects. The data gathered in this study will further enable clinical
development of GSK3732394 in HIV-infected subjects. Approximately 72 healthy subjects will be
randomized in the FTIH study. Part 1 will be the single ascending dose (SAD) phase and Part 2
will be the multiple ascending dose (MAD) phase. Each subject in the SAD cohort will receive
a single dose of blinded GSK3732394 or blinded placebo (PBO) in 6:2 ratio. Part 1 will
consist of five ascending single-dose cohorts with an additional expansion cohort included as
needed. Part 2 will consist of up to three ascending repeat-dose cohorts (MAD Cohorts 1, 2,
and 3), randomized to four weekly doses of blinded GSK3732394 or blinded PBO in 6:2 ratio to
be administered on Days 1, 8, 15, and 22.