[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial to investigate the safety, tolerability, and pharmacokinetic characteristics of TLZ-16-CL capsules in healthy subjects after single-dose escalation and repeated doses
1.主要目的:
评估受试者(健康成年志愿者)单次和多次口服不同剂量 TLZ-16-CL胶囊后的安全性、耐受性,并为后期临床试验推荐剂量提供依据。
2.次要目的:
2.1.评估健康成年受试者单次和多次口服不同剂量 TLZ-16-CL胶囊后TLZ-16-CL原 型及其代谢物的药代动力学(PK)特征;
2.2.评估中国健康成年受试者单次口服不同剂量 TLZ-16-CL 胶囊后尿液中 TLZ-16-CL原型及其代谢物的含量。
[Translation] 1. Primary purpose:
To evaluate the safety and tolerability of subjects (healthy adult volunteers) after single and multiple oral administration of different doses of TLZ-16-CL capsules, and to provide a basis for the recommended dose in later clinical trials.
2. Secondary purpose:
2.1. To evaluate the pharmacokinetic (PK) characteristics of TLZ-16-CL prototype and its metabolites after single and multiple oral administration of different doses of TLZ-16-CL capsules in healthy adult subjects;
2.2. To evaluate the content of TLZ-16-CL prototype and its metabolites in urine after single oral administration of different doses of TLZ-16-CL capsules in healthy adult subjects in China.