Single under-the-skin injection of HRS-9563 for people with mild high blood pressure

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.

This will test whether a single under-the-skin injection of HRS-9563 is safe and tolerated in adults with mild high blood pressure.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07117474 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 study giving a single subcutaneous injection of HRS-9563 to adults with mild primary hypertension and following them for safety, tolerability, pharmacokinetics, and pharmacodynamics. Eligible participants are men or infertile women aged 18–65 with BMI 19–28 kg/m2 who are not on antihypertensive therapy and meet sitting and 24-hour ambulatory systolic blood pressure criteria. Key exclusions include secondary hypertension, diabetes, orthostatic hypotension, very high diastolic pressure, recent antihypertensive use, or abnormal lab findings. The study is conducted at Zhejiang Provincial People's Hospital with serial blood sampling and blood pressure monitoring before and after dosing.

Who should consider this trial

Good fit: Adults aged 18–65 with mild primary hypertension (sitting SBP 130–159 mmHg and 24-hour ambulatory SBP ≥130 mmHg), BMI 19–28 kg/m2, not currently taking antihypertensive medications.

Not a fit: People with secondary hypertension, type 2 diabetes, mean sitting DBP ≥100 mmHg, orthostatic hypotension, recent antihypertensive use, or disqualifying lab abnormalities are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If safe and effective, HRS-9563 could become a new single-dose subcutaneous option that may simplify treatment for people with mild hypertension.

How similar studies have performed: HRS-9563 appears to be a novel compound with no widely published clinical data, while other single-dose subcutaneous agents for cardiovascular conditions have shown mixed early-phase safety and pharmacodynamic signals.

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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yuhan Guo

Conditions Subjects With Mild Hypertension