NCT07551167RecruitingPhase 1
A Clinical Study of HRS-5765 in Healthy Participants
A Randomized, Double-Blind, Dose-Escalation, Placebo-Parallel Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HRS-5765 in Healthy Subjects, as Well as the Effect of Food on the Pharmacokinetics of HRS-5765 and the Effect of HRS-5765 on CYP3A4 Metabolic Enzymes
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- 20 May 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Diseases
- Heart failure
- NCT number
- NCT07551167
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 74
- From 20 May 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe infection, trauma, major surgery within 3 months before screening; Planned surgery during the trial.
- Blood donation/severe blood loss (≥ 400 mL) within 3 months, blood transfusion within 4 weeks before screening; Planned blood donation during the trial.
- History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned.
- Participation during the trial; Within 5 half-lives of a prior drug (whichever is longer).
- Smoking history (≥ 5 cigarettes/day) within 4 weeks before screening; Inability to abstain from tobacco during the trial.
Other illness
- A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
- Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.
Other
- Special dietary requirements and inability to comply with the unified diet.
- Difficulty in swallowing/venous blood collection; Intolerance to intensive blood sampling.
- Other circumstances deemed unsuitable for trial participation by researcher.
Who the study is looking for
- Healthy men and women aged 18 to 65 years old at informed consent signing.
- 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.
- Have no clinically significant abnormalities at screening and baseline.
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.