Actively Recruiting
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.
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-08-12
60
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or infertile women aged 18 to 65 years
- Body mass index between 19 and 28 kg/m2
- Mild primary hypertension without antihypertensive treatment
- Mean sitting systolic blood pressure between 130 and 159 mmHg during screening and baseline
- Mean 24-hour ambulatory systolic blood pressure of at least 130 mmHg during screening
You will not qualify if you...
- Abnormal daily life rhythm
- Blood biochemical indicators outside acceptable standards during screening or baseline
- Secondary hypertension diagnosis
- Mean sitting diastolic blood pressure of 100 mmHg or higher
- Orthostatic hypotension
- History of type 2 diabetes or poorly controlled blood glucose
- Recent use of antihypertensive or blood pressure-affecting medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 314408
Actively Recruiting
Research Team
Y
Yuhan Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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