A Clinical Study of HRS-5765 in Healthy Participants

A Randomized, Double-Blind, Dose-Escalation, Placebo-Parallel Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HRS-5765 in Healthy Subjects, as Well as the Effect of Food on the Pharmacokinetics of HRS-5765 and the Effect of HRS-5765 on CYP3A4 Metabolic Enzymes

The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants.

Inclusion Criteria:

1. Healthy men and women aged 18 to 65 years old at informed consent signing.
2. Male body weight ≥ 50 kg and < 90.0 kg, female ≥ 45 kg and < 90.0 kg; BMI 19 to 26 kg/m² at screening and baseline.
3. Have no clinically significant abnormalities at screening and baseline.
4. Fertile females and males with fertile female partners: effective contraception consent, and sustained until 1 week after the last dose (abstinence or highly effective contraception); no sperm/egg donation.

Exclusion Criteria:

1. A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
2. Severe infection, trauma, major surgery within 3 months before screening; Planned surgery during the trial.
3. Blood donation/severe blood loss (≥ 400 mL) within 3 months, blood transfusion within 4 weeks before screening; Planned blood donation during the trial.
4. History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned.
5. Participation during the trial; Within 5 half-lives of a prior drug (whichever is longer).
6. Smoking history (≥ 5 cigarettes/day) within 4 weeks before screening; Inability to abstain from tobacco during the trial.
7. Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.
8. Special dietary requirements and inability to comply with the unified diet.
9. Difficulty in swallowing/venous blood collection; Intolerance to intensive blood sampling.
10. Other circumstances deemed unsuitable for trial participation by researcher.