A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3732394 in Healthy Participants
收藏DataCite Commons2024-11-27 更新2026-05-07 收录
下载链接:
https://search.vivli.org/doiLanding/studies/PR00009215/isLanding
下载链接
链接失效反馈官方服务:
资源简介:
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.
提供机构:
Vivli
创建时间:
2023-08-15



