Subjects With Mild Hypertension
Conditions
Brief summary
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
Interventions
DRUGHRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or infertile women aged 18-65 years (inclusive); 2. Body mass index in the range of 19-28 kg/m2 (inclusive); 3. Mild primary hypertension, without antihypertensive treatment, with a mean sitting systolic blood pressure ≥ 130 mmHg and ≤ 159 mmHg during screening and baseline, and a mean 24-hour ambulatory systolic blood pressure ≥ 130 mmHg during screening.
Exclusion criteria
1. Abnormal daily life rhythm; 2. Any blood biochemical indicator during screening or baseline did not meet the standards in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of any adverse events | Evaluation was performed up to Day169 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration of HRS-9563 (Cmax) | Evaluation was performed up to Day3 |
| Time to Cmax (Tmax) | Evaluation was performed up to Day3 |
| Area under the concentration-time curve from 0 to the last measurable time point after HRS-9563 administration (AUC0-t) | Evaluation was performed up to Day3 |
| Area under the concentration-time curve from time 0 to infinity after HRS-9563 administration (AUC0-inf) | Evaluation was performed up to Day3 |
| Terminal elimination half-life of HRS-9563 (t1/2 | Evaluation was performed up to Day3 |
| Apparent clearance of HRS-9563 (CL/F) | Evaluation was performed up to Day3 |
| Apparent volume of distribution during terminal elimination phase of HRS-9563 (Vz/F) | Evaluation was performed up to Day3 |
| Cumulative amount of drug excreted in urine (Ae,urine) | Evaluation was performed up to Day3 |
| Cumulative percentage of dose recovered in urine (Fe,urine) | Evaluation was performed up to Day3 |
Countries
China
Outcome results
None listed