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Phase 1 Study Evaluating Safety and Food Effects of ZL-65 Tablet in Healthy Adults in China
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-08-11
108
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetic and pharmacodynamic behavior of a single oral dose of ZL-65 tablets in healthy adult participants. The study also explores how food intake affects the drugs pharmacokinetics. This Phase 1 clinical trial targets healthy adults aged 18 to 45 years. Participants are randomly assigned to receive either ZL-65 tablets or matching placebo tablets in a dose-escalation design. Dose levels include 5mg, 10mg, 25mg, 50mg, 75mg, 100mg, and 125mg. This study also assesses the impact of food on the drugs absorption and metabolism. During the trial, participants are closely monitored for adverse events from day 1 to day 7 after dosing. Pharmacokinetic parameters such as maximum concentration, time to maximum concentration, area under the curve, and half-life are measured over 72 hours. The study includes safety assessments and collection of blood samples to understand how the drug behaves in the body. The total duration of participation varies according to the dose escalation and assessment schedule.
CONDITIONS
Brief Title
Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China
Research Team
W
Wang Fangmei
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