A Clinical Study of HRS-5765 in Healthy Participants
ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChengdu Suncadia Medicine Co., Ltd.
About this trial
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HRS-5765 Tablet
- HRS-5765 Tablet Placebo
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov