A Clinical Study of HRS-7156 in Healthy Participants
ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy men and women aged 18 to 55 years old at informed consent signing;
Male body weight ≥50 kg, female ≥45 kg; BMI 18.5 to 30 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 2 weeks before 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 8 weeks, 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-7156
DrugHRS-7156, specified dose on specified day.
HRS-7156 placebo
DrugHRS-7156 placebo, specified dose on specified day.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: HRS-7156Experimental treatment 1 intervention
Group B: HRS-7156 placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse event (AE) and serious adverse event (SAE)
Safety: Incidence of adverse event (AE) and serious adverse event (SAE).
Time frame
Up to 14 days.Secondary outcomes
1
Area under the concentration time curve (AUC)
Pharmacokinetics (PK) parameter of HRS-7156.
Time frame
Day 1 - Day 9.2
Maximum Plasma Concentration (Cmax)
Pharmacokinetics (PK) parameter of HRS-7156.
Time frame
Day 1 - Day 9.3
Time to maximum plasma concentration (Tmax)
Pharmacokinetics (PK) parameter of HRS-7156.
Time frame
Day 1 - Day 9.4
Renal clearance (CLR)
Pharmacokinetics (PK) parameter of HRS-7156.
Time frame
Day 1 - Day 2.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov