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.
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Subjects With Mild Hypertension
In brief
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
Key facts
- Study ID
- NCT07117474
- Run by
- Fujian Shengdi Pharmaceutical Co., Ltd.
- People needed
- 60
- Starts
- 2024-12-24
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-08-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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