Recruiting

HRS-9563 Injection for Mild Hypertension

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What is being tested

HRS-9563, placebo

Drug
Who is being recruted

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorFujian Shengdi Pharmaceutical Co., Ltd.
Study ContactYuhan Guo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 24, 2024

Actual date on which the first participant was enrolled.

This study is exploring a new treatment option for individuals with mild hypertension, a condition where blood pressure is higher than normal but not severely high. The research focuses on a medication called HRS-9563 and aims to understand if it is safe and well-tolerated when given as a single injection under the skin. The study targets those with mild hypertension, hoping to find a potentially effective treatment that could help manage blood pressure in a new way. Participants in the study will receive a single subcutaneous, or under the skin, injection of HRS-9563. The study is set up in a way that neither the participants nor the researchers know who receives the active medication and who receives a placebo, ensuring unbiased results. Researchers will monitor participants closely to evaluate how their bodies react to the injection, focusing on any side effects and how well the medication is tolerated. This careful monitoring is crucial to ensure participant safety and to gather accurate data on the medication's effects.

Official TitleSafety, 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.
NCT07117474
Principal SponsorFujian Shengdi Pharmaceutical Co., Ltd.
Study ContactYuhan Guo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Males or infertile women aged 18-65 years (inclusive);

Body mass index in the range of 19-28 kg/m2 (inclusive);

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.

7 exclusion criteria prevent from participating
Abnormal daily life rhythm;

Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;

Secondary hypertension;

Mean sitting diastolic blood pressure ≥ 100 mmHg;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhejiang Provincial People's Hospital

Hangzhou, ChinaOpen Zhejiang Provincial People's Hospital in Google Maps
Recruiting
One Study Center
HRS-9563 Injection for Mild Hypertension | PatLynk