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Not yet recruiting Phase 1 NCT07551167

A Phase I Study of HRS-5765 in Healthy Participants

Phase 1 – testing safety in a small group of people
Conditions: Heart Failure

Sponsor: Chengdu Suncadia Medicine Co., Ltd.

trial.available_in: БГ
Overview
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
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.
Interventions
HRS-5765 Tablet
DRUG
HRS-5765 Tablet Placebo
DRUG
Locations 1
China (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing , Beijing Municipality
Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.01.2027
Registry ID
NCT07551167
Source
clinicaltrials.gov
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