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.
Trial Parameters
Brief Summary
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
Eligibility Criteria
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 exclusion criteria; 3. Secondary hypertension; 4. Mean sitting diastolic blood pressure ≥ 100 mmHg; 5. Orthostatic hypotension; 6. History of type 2 diabetes mellitus or poorly controlled blood glucose; 7. Recently received any antihypertensive medications or medications that affect blood pressure.