HRS-5765 tablet safety and pharmacology in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial in healthy adults will assess the safety, tolerability, and pharmacokinetics of a single and/or multiple doses of HRS-5765, with comparison to placebo. Participants will undergo screening, dosing, and safety monitoring, along with PK/PD measurements to understand absorption, distribution, metabolism, and excretion. The study is conducted at a single center in Beijing and is sponsored by Chengdu Suncadia Medicine, focusing on healthy volunteers to inform future research in patients with heart conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Hui Xu
• Email: hui.xu.hx107@hengrui.com
• Phone: +86 0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.