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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.

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.

Recruiting
18-65 years
All
Phase 1

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Overview

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

Eligibility

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 details
    Subjects With Mild Hypertension

NCT07117474

Fujian Shengdi Pharmaceutical Co., Ltd.

16 October 2025

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