NCT07551167

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1 heart-failure

Timeline
8mo left

Started Apr 2026

Shorter than P25 for phase_1 heart-failure

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Apr 2026Jan 2027

Study Start

First participant enrolled

April 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 20, 2026

Last Update Submit

April 26, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse event (AE)

    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)

    Safety parameter.

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

Secondary Outcomes (4)

  • Area under the concentration-time curve (AUC)

    Day 1-Day 18.

  • Maximum plasma concentration (Cmax)

    Day 1-Day 18.

  • Time to maximum plasma concentration (Tmax)

    Day 1-Day 18.

  • Apparent clearance (CL/F)

    Day 1-Day 18.

Study Arms (2)

HRS-5765 group

EXPERIMENTAL

Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765.

Drug: HRS-5765 Tablet

HRS-5765 placebo group

PLACEBO COMPARATOR

Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765 placebo.

Drug: HRS-5765 Tablet Placebo

Interventions

HRS-5765 TabletDRUG

HRS-5765 tablet, specified dose on specified day.

HRS-5765 group
HRS-5765 Tablet PlaceboDRUG

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

HRS-5765 placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Hui Xu

CONTACT

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

Chang Shu

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: HRS-5765 compared with placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

CN(1)