Heart Failure
Conditions
Brief summary
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
Interventions
DRUGHRS-7156
HRS-7156, specified dose on specified day.
DRUGHRS-7156 placebo
HRS-7156 placebo, specified dose on specified day.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HRS-7156 compared with placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy men and women aged 18 to 55 years old at informed consent signing; 2. Male body weight ≥50 kg, female ≥45 kg; BMI 18.5 to 30 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 2 weeks before 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 8 weeks, 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; positive smoke screening at screening/baseline; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse event (AE) and serious adverse event (SAE) | Up to 14 days. | Safety: Incidence of adverse event (AE) and serious adverse event (SAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration time curve (AUC) | Day 1 - Day 9. | Pharmacokinetics (PK) parameter of HRS-7156. |
| Maximum Plasma Concentration (Cmax) | Day 1 - Day 9. | Pharmacokinetics (PK) parameter of HRS-7156. |
| Time to maximum plasma concentration (Tmax) | Day 1 - Day 9. | Pharmacokinetics (PK) parameter of HRS-7156. |
| Renal clearance (CLR) | Day 1 - Day 2. | Pharmacokinetics (PK) parameter of HRS-7156. |
| Renin concentration of HRS-7156 | Day 1 - Day 9. | Pharmacodynamics (PD) endpoint of HRS-7156. |
Countries
China
Contacts
CONTACTKaiyun Zhang
CONTACTSheng Qi
Outcome results
None listed