A Clinical Study of HRS-8797 in Healthy Participants

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect Following Single and Multiple Oral Doses of HRS-8797 Tablets in Healthy Subjects

The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.

Inclusion Criteria:

1. Healthy men and women aged 18 to 55 years old at informed consent signing
2. Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 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 4 weeks 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.