A Clinical Study of HRS-5765 in Healthy Participants

May 21, 2026 updated by: Chengdu Suncadia Medicine Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Recruiting
        • Beijing AnZhen Hospital, Capital Medical University
        • Principal Investigator:
          • Yang Lin
        • Principal Investigator:
          • Shan Jing
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-5765 group
Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765.
Drug: HRS-5765 Tablet
HRS-5765 tablet, specified dose on specified day.
Placebo Comparator: HRS-5765 placebo group
Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765 placebo.
Drug: HRS-5765 Tablet Placebo
HRS-5765 tablet placebo, specified dose on specified day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
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.
Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve (AUC)
Time Frame: Day 1-Day 18.
PK parameter of HRS-5765.
Day 1-Day 18.
Maximum plasma concentration (Cmax)
Time Frame: Day 1-Day 18.
PK parameter of HRS-5765.
Day 1-Day 18.
Time to maximum plasma concentration (Tmax)
Time Frame: Day 1-Day 18.
PK parameter of HRS-5765.
Day 1-Day 18.
Apparent clearance (CL/F)
Time Frame: Day 1-Day 18.
PK parameter of HRS-5765.
Day 1-Day 18.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: Day 1-Day 18.
PK parameter of HRS-5765.
Day 1-Day 18.
Time to maximum plasma concentration (Tmax)
Time Frame: Day 1-Day 18.
PK parameter of HRS-5765.
Day 1-Day 18.
Apparent clearance (CL/F)
Time Frame: Day 1-Day 18.
PK parameter of HRS-5765.
Day 1-Day 18.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-5765-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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