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โ† Trials
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A Clinical Study of HRS-7156 in Healthy Participants

RecruitingPhase 1Ages 18 Years - 55 YearsAllShandong Suncadia Medicine Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Healthy men and women aged 18 to 55 years old at informed consent signing; 2. Male body weight โ‰ฅ50 kg, female โ‰ฅ45 kg; BMI 18.5 to 30 kg/mยฒ 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 (โ‰ฅ400 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 (โ‰ฅ5 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.
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What it tests

  • HRS-7156
  • HRS-7156 placebo
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Where

1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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