HRS-7156: HRS-7156, specified dose on specified day.
HRS-7156 placebo: HRS-7156 placebo, specified dose on specified day.
Study summary
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Incidence of adverse event (AE) and serious adverse event (SAE) — Up to 14 days. Safety: Incidence of adverse event (AE) and serious adverse event (SAE).
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital Affiliated to Fudan University
Shanghai
Shanghai Municipality
Recruiting
More Shandong Suncadia Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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