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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07551167

Enrollment

Registered

2026-04-24

Start date

2026-05-20

Completion date

2027-01-01

Last updated

2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief 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.

Interventions

DRUGHRS-5765 Tablet

HRS-5765 tablet, specified dose on specified day.

DRUGHRS-5765 Tablet Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

HRS-5765 compared with placebo.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse event (AE)	Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).	Safety parameter.
Incidence of serious adverse event (SAE)	Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).	Safety parameter.

Secondary

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

Countries

China

Contacts

CONTACTHui Xu

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

CONTACTChang Shu

chang.shu@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026