Dataset from A Randomized Double Blinded (Sponsor Unblind), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Selective Androgen Receptor Modulator (SARM) in Single and Repeat Doses in Healthy Male Subjects

This study is the first administration of GSK2881078 to humans. The intention of this study is to provide sufficient confidence in the safety of the molecule to inform progression to further repeat dose and proof of concept studies. This study will include approximately 52 subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5) will include three cohorts of 12 healthy male subjects to examine the safety, tolerability, PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total duration of the study including screening and follow-up, is not expected to exceed 70 days.

本研究为GSK2881078的首次人体给药试验。本研究旨在为该化合物的安全性提供充分依据，以支持后续重复给药试验及概念验证研究的推进。本研究共纳入约52名受试者，分为两个阶段。
A阶段包含两个队列，各纳入8名受试者，用于评估递增单次口服GSK2881078的安全性、耐受性及药代动力学（Pharmacokinetics, PK）特性；队列1与队列2均纳入健康男性受试者。
B阶段（队列3、4、5）包含三个队列，各纳入12名健康男性受试者，用于考察14天重复给药方案下GSK2881078的安全性、耐受性、药代动力学（PK）及药效动力学（Pharmacodynamics, PD）特性。
本研究总时长（含筛选与随访阶段）预计不超过70天。