[Translation] A randomized, double-blind, placebo-controlled, single-ascending dose phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of BC0305 capsules in healthy subjects
主要目的:评价健康受试者单剂量口服 BC0305 胶囊的安全性和耐受性,为该药多剂量临床试验方案的制定提供参考依据。
次要目的:评价健康受试者单剂量口服 BC0305 胶囊的药代动力学和药效学特征。评价 BC0305 胶囊给药在体内的代谢产物,及主要代谢产物的 PK 特征(如适用)。
[Translation] Primary objective: To evaluate the safety and tolerability of a single oral dose of BC0305 capsules in healthy subjects, and to provide a reference for the formulation of a multi-dose clinical trial protocol for the drug.
Secondary objective: To evaluate the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of BC0305 capsules in healthy subjects. To evaluate the metabolites of BC0305 capsules in vivo, and the PK characteristics of the main metabolites (if applicable).