A Clinical Study of HRS-7156 in Healthy Participants

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Oral Doses of HRS-7156 in Healthy Participants

The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 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 18.5 to 30 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 2 weeks before 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 8 weeks, 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; positive smoke screening at screening/baseline;
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.