Not Yet RecruitingPhase 1

A Clinical Study of HRS-5765 in Healthy Participants

China74 participantsStarted 2026-04

Plain-language summary

The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
✕. 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.
✕. Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.
✕. Special dietary requirements and inability to comply with the unified diet.

What they're measuring

Incidence of adverse event (AE)

Timeframe: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).

Incidence of serious adverse event (SAE)

Timeframe: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).

Trial details

NCT IDNCT07551167

SponsorChengdu Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Hui Xu

+86 0518-82342973 hui.xu.hx107@hengrui.com

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