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NCT Number: NCT07117474

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.

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 314408, China

Location status: Recruiting

Location contact

Ping Huang

PRINCIPAL_INVESTIGATOR

Yiwen Zhang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Orthostatic hypotension;
  • History of type 2 diabetes mellitus or poorly controlled blood glucose;
  • Recently received any antihypertensive medications or medications that affect blood pressure.

Treatment and study plan

HRS-9563, placebo

Drug

A single subcutaneous injection of HRS-9563 injection or placebo was administered

Primary outcomes

  1. Incidence and severity of any adverse events

    Time frame: Evaluation was performed up to Day169

Secondary outcomes

  1. Maximum observed plasma concentration of HRS-9563 (Cmax)

    Time frame: Evaluation was performed up to Day3

  2. Time to Cmax (Tmax)

    Time frame: Evaluation was performed up to Day3

  3. Area under the concentration-time curve from 0 to the last measurable time point after HRS-9563 administration (AUC0-t)

    Time frame: Evaluation was performed up to Day3

  4. Area under the concentration-time curve from time 0 to infinity after HRS-9563 administration (AUC0-inf)

    Time frame: Evaluation was performed up to Day3

  5. Terminal elimination half-life of HRS-9563 (t1/2

    Time frame: Evaluation was performed up to Day3

  6. Apparent clearance of HRS-9563 (CL/F)

    Time frame: Evaluation was performed up to Day3

  7. Apparent volume of distribution during terminal elimination phase of HRS-9563 (Vz/F)

    Time frame: Evaluation was performed up to Day3

  8. Cumulative amount of drug excreted in urine (Ae,urine)

    Time frame: Evaluation was performed up to Day3

  9. Cumulative percentage of dose recovered in urine (Fe,urine)

    Time frame: Evaluation was performed up to Day3

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.