Recruiting NCT07601087
A Clinical Study of HRS-7156 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-7156, HRS-7156 placebo.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Oral Doses of HRS-7156 in Healthy Participants
Overview
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
Interventions
- Drug HRS-7156
HRS-7156, specified dose on specified day. - Drug HRS-7156 placebo
HRS-7156 placebo, specified dose on specified day.
Primary outcome measures
- Incidence of adverse event (AE) and serious adverse event (SAE) [Time frame: Up to 14 days.]
Secondary outcome measures (5)
- Area under the concentration time curve (AUC) [Time frame: Day 1 - Day 9.]
- Maximum Plasma Concentration (Cmax) [Time frame: Day 1 - Day 9.]
- Time to maximum plasma concentration (Tmax) [Time frame: Day 1 - Day 9.]
- Renal clearance (CLR) [Time frame: Day 1 - Day 2.]
- Renin concentration of HRS-7156 [Time frame: Day 1 - Day 9.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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 smoke screening at screening/baseline;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital Affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT07601087 · HRS-7156-101