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非在研适应症- |
最高研发阶段临床2期 |
首次获批国家/地区- |
首次获批日期- |
A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of BT051 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending doses of BT051 in healthy male or female volunteers aged 18 to <50 years. A total of 50 subjects will be randomized to receive a single oral dose of BT051 or matching placebo in a ratio of 4 active:1 placebo in 5 ascending dose cohorts (10 subjects per cohort) at active dose levels of 100mg, 300mg, 700mg, 1500mg or 3500mg. The study Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) occurred in a cohort through Day 3, as well as review cumulative safety data for all previous cohorts and any available pharmacokinetic (PK) data before proceeding to dosing in the next cohort.
100 项与 Bacainn Therapeutics, Inc. 相关的临床结果
0 项与 Bacainn Therapeutics, Inc. 相关的专利(医药)
100 项与 Bacainn Therapeutics, Inc. 相关的药物交易
100 项与 Bacainn Therapeutics, Inc. 相关的转化医学