Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-5765 Tablet

    Drug

    HRS-5765 tablet, specified dose on specified day.

  • HRS-5765 Tablet Placebo

    Drug

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

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: HRS-5765 groupExperimental treatment 1 intervention
Group B: HRS-5765 placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse event (AE)

Safety parameter.

Time frame
Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
2

Incidence of serious adverse event (SAE)

Safety parameter.

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

Secondary outcomes

1

Area under the concentration-time curve (AUC)

PK parameter of HRS-5765.

Time frame
Day 1-Day 18.
2

Maximum plasma concentration (Cmax)

PK parameter of HRS-5765.

Time frame
Day 1-Day 18.
3

Time to maximum plasma concentration (Tmax)

PK parameter of HRS-5765.

Time frame
Day 1-Day 18.
4

Apparent clearance (CL/F)

PK parameter of HRS-5765.

Time frame
Day 1-Day 18.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now