A Phase I Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Effects of Oral Doses of HRS-5765 in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-5765 in healthy adults aged 18 to 65 years. This phase I randomized, double-blind study also explores how food affects HRS-5765s pharmacokinetics and its impact on certain metabolic enzymes. The trial is sponsored by Chengdu Suncadia Medicine Co., Ltd. and focuses on healthy volunteers without significant health issues. Participants will be randomly assigned to receive either a specified dose of HRS-5765 tablet or a matching placebo. The study includes single and multiple oral dosing periods, with dose escalation across cohorts. The trial includes a food effect period to assess medication behavior with meals. Treatments are given orally, and participants remain blinded to their assigned group throughout the trial. During the study, participants are closely monitored for adverse events and serious adverse events from day 1 through day 21, depending on the dosing period. Researchers will measure drug levels in the blood, including maximum concentration, time to reach this level, overall exposure, and clearance from the body over 18 days. Safety assessments, laboratory tests, physical exams, and adherence to diet and contraception requirements are also conducted. The total study duration varies by participant depending on dosing and follow-up periods.

A Clinical Study of HRS-5765 in Healthy Participants