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.
NCT ID: NCT07117474
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2024-12-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group 1: Injection of HRS-9563 or placebo
HRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Treatment group 2: Injection of HRS-9563 or placebo
HRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Treatment group 3: Injection of HRS-9563 or placebo
HRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Treatment group 4: Injection of HRS-9563 or placebo
HRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Treatment group 5: Injection of HRS-9563 or placebo
HRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Interventions
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HRS-9563, placebo
A single subcutaneous injection of HRS-9563 injection or placebo was administered
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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HRS-9563-101
Identifier Type: -
Identifier Source: org_study_id
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