Recruiting NCT07117474
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of HRS-9563 in Subjects With Mild Hypertension: a Randomized, Double-blind, Placebo-controlled Phase I Study.
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-9563, placebo.
- Who it may be relevant to
- Registry conditions: Subjects With Mild Hypertension. Basic parameters: 18 years — 65 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 →
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Overview
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
Interventions
- Drug HRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Primary outcome measures
- Incidence and severity of any adverse events [Time frame: Evaluation was performed up to Day169]
Secondary outcome measures (9)
- Maximum observed plasma concentration of HRS-9563 (Cmax) [Time frame: Evaluation was performed up to Day3]
- Time to Cmax (Tmax) [Time frame: 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) [Time frame: Evaluation was performed up to Day3]
- Area under the concentration-time curve from time 0 to infinity after HRS-9563 administration (AUC0-inf) [Time frame: Evaluation was performed up to Day3]
- Terminal elimination half-life of HRS-9563 (t1/2 [Time frame: Evaluation was performed up to Day3]
- Apparent clearance of HRS-9563 (CL/F) [Time frame: Evaluation was performed up to Day3]
- Apparent volume of distribution during terminal elimination phase of HRS-9563 (Vz/F) [Time frame: Evaluation was performed up to Day3]
- Cumulative amount of drug excreted in urine (Ae,urine) [Time frame: Evaluation was performed up to Day3]
- Cumulative percentage of dose recovered in urine (Fe,urine) [Time frame: Evaluation was performed up to Day3]
Eligibility criteria
Inclusion criteria
- Males or infertile women aged 18-65 years (inclusive);
- Body mass index in the range of 19-28 kg/m2 (inclusive);
- 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
- Abnormal daily life rhythm;
- Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;
- Secondary hypertension;
- Mean sitting diastolic blood pressure ≥ 100 mmHg;
- Orthostatic hypotension;
- History of type 2 diabetes mellitus or poorly controlled blood glucose;
- Recently received any antihypertensive medications or medications that affect blood pressure.
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
- Zhejiang Provincial People's Hospital — Hangzhou
Identifiers
NCT: NCT07117474 · HRS-9563-101