Actively Recruiting
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Trial of Oral HRS-5765 in Healthy Adults to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and CYP3A4 Enzyme Interaction
Led by Chengdu Suncadia Medicine Co., Ltd. · Updated on 2026-05-26
74
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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-5765's 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.
CONDITIONS
Brief Title
A Clinical Study of HRS-5765 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men and women aged 18 to 65 years at informed consent signing
- Male body weight 50 kg to less than 90 kg; female body weight 45 kg to less than 90 kg
- Body mass index between 19 and 26 kg/m² at screening and baseline
- No clinically significant abnormalities at screening and baseline
- Fertile males and females with fertile partners must agree to effective contraception or abstinence until one week after last dose; no sperm or egg donation
You will not qualify if you...
- History or current severe diseases affecting multiple systems or interfering with trial results
- Severe infection, trauma, or major surgery within 3 months before screening; planned surgery during trial
- Blood donation or severe blood loss of 400 mL or more within 3 months; blood transfusion within 4 weeks before screening; planned blood donation during trial
- History of drug abuse or dependence; positive urine drug test at screening
- Participation in other clinical trials within 3 months before screening or planned participation
- Use of drugs within 5 half-lives before the trial
- Smoking 5 or more cigarettes per day within 4 weeks before screening or inability to abstain during trial
- Positive test for hepatitis B surface antigen, HIV antibody, syphilis antibody, or hepatitis C antibody at screening
- Special dietary requirements incompatible with study diet
- Difficulty swallowing or venous blood collection; intolerance to intensive blood sampling
- Any other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days depending on the cohort
Participants receive specified doses of HRS-5765 or placebo to evaluate safety and drug behavior.
Multiple visits during dosing periods up to 21 days
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
H
Hui Xu
C
Chang Shu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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