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.

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Subjects With Mild Hypertension

Treatments: Drug: HRS-9563, placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07117474

HRS-9563-101

Details and patient eligibility

About

To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 5 patient groups

Treatment group 1: Injection of HRS-9563 or placebo

Experimental group

Treatment:

Drug: HRS-9563, placebo

Treatment group 2: Injection of HRS-9563 or placebo

Experimental group

Treatment:

Drug: HRS-9563, placebo

Treatment group 3: Injection of HRS-9563 or placebo

Experimental group

Treatment:

Drug: HRS-9563, placebo

Treatment group 4: Injection of HRS-9563 or placebo

Experimental group

Treatment:

Drug: HRS-9563, placebo

Treatment group 5: Injection of HRS-9563 or placebo

Experimental group

Treatment:

Drug: HRS-9563, placebo