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.

Not Applicable

Recruiting

• Conditions: Subjects With Mild Hypertension
• Interventions: Drug: HRS-9563, placebo

• Registration Number: NCT07117474
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-24
• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 1: Injection of HRS-9563 or placebo	HRS-9563, placebo	-
Treatment group 2: Injection of HRS-9563 or placebo	HRS-9563, placebo	-
Treatment group 3: Injection of HRS-9563 or placebo	HRS-9563, placebo	-
Treatment group 4: Injection of HRS-9563 or placebo	HRS-9563, placebo	-
Treatment group 5: Injection of HRS-9563 or placebo	HRS-9563, placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of any adverse events	Evaluation was performed up to Day169

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from 0 to the last measurable time point after HRS-9563 administration (AUC0-t)	Evaluation was performed up to Day3
Cumulative amount of drug excreted in urine (Ae,urine)	Evaluation was performed up to Day3
Cumulative percentage of dose recovered in urine (Fe,urine)	Evaluation was performed up to Day3
Maximum observed plasma concentration of HRS-9563 (Cmax)	Evaluation was performed up to Day3
Time to Cmax (Tmax)	Evaluation was performed up to Day3
Area under the concentration-time curve from time 0 to infinity after HRS-9563 administration (AUC0-inf)	Evaluation was performed up to Day3
Terminal elimination half-life of HRS-9563 (t1/2	Evaluation was performed up to Day3
Apparent clearance of HRS-9563 (CL/F)	Evaluation was performed up to Day3
Apparent volume of distribution during terminal elimination phase of HRS-9563 (Vz/F)	Evaluation was performed up to Day3

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China