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NCT Number: NCT07551167

A Clinical Study of HRS-5765 in Healthy Participants

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Difficulty in swallowing/venous blood collection; Intolerance to intensive blood sampling.
  • Other circumstances deemed unsuitable for trial participation by researcher.

Treatment and study plan

HRS-5765 Tablet

Drug

HRS-5765 tablet, specified dose on specified day.

HRS-5765 Tablet Placebo

Drug

HRS-5765 tablet placebo, specified dose on specified day.

Primary outcomes

  1. Incidence of adverse event (AE)

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

    Safety parameter.

  2. Incidence of serious adverse event (SAE)

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

    Safety parameter.

Secondary outcomes

  1. Area under the concentration-time curve (AUC)

    Time frame: Day 1-Day 18.

    PK parameter of HRS-5765.

  2. Maximum plasma concentration (Cmax)

    Time frame: Day 1-Day 18.

    PK parameter of HRS-5765.

  3. Time to maximum plasma concentration (Tmax)

    Time frame: Day 1-Day 18.

    PK parameter of HRS-5765.

  4. Apparent clearance (CL/F)

    Time frame: Day 1-Day 18.

    PK parameter of HRS-5765.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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