A Double-blind, Randomized, Dose-escalation Phase I Trial Evaluating Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of HRS-3095 Oral Doses in Healthy Adults

What this Trial Is About

Researchers are studying the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-3095 in healthy adults aged 18 to 55 years. This Phase I clinical trial also explores how food affects HRS-3095 absorption and examines its impact on the CYP3A4 enzyme system involved in drug metabolism. The study is led by Chengdu Suncadia Medicine Co., Ltd. and includes a randomized, double-blind design with placebo control. Participants will receive either HRS-3095 tablets or matching placebo tablets in a dose-escalation format. The study evaluates the effects of both single and multiple doses of the drug, monitoring how the body processes it over time. The trial includes assessments of drug concentration, time to maximum concentration, and elimination half-life, as well as investigations into the drug’s clearance and distribution. The impact of food intake on these factors will also be studied. During the study, participants will be monitored for up to 21 days to record any adverse events or serious adverse events. Detailed measurements of pharmacokinetic parameters will be taken for up to 17 days. Healthy volunteers will undergo clinical evaluations to confirm no significant health abnormalities before enrollment. Participants will be followed closely to ensure safety and to collect data on how the drug behaves in the body throughout the trial period.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes