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.

NCT07117474 | Completed Phase 1

• 1 other identifier: HRS-9563-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Subjects With Mild Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of any adverse events

  Evaluation was performed up to Day169

Secondary Outcomes (9)

• Maximum observed plasma concentration of HRS-9563 (Cmax)

  Evaluation was performed up to Day3

• Time to Cmax (Tmax)

  Evaluation was performed up to Day3

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

  Evaluation was performed up to Day3

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

  Evaluation was performed up to Day3

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

  Evaluation was performed up to Day3

Study Arms (5)

Treatment group 1: Injection of HRS-9563 or placebo

EXPERIMENTAL

Drug: HRS-9563, placebo

Treatment group 2: Injection of HRS-9563 or placebo

EXPERIMENTAL

Drug: HRS-9563, placebo

Treatment group 3: Injection of HRS-9563 or placebo

EXPERIMENTAL

Drug: HRS-9563, placebo

Treatment group 4: Injection of HRS-9563 or placebo

EXPERIMENTAL

Drug: HRS-9563, placebo

Treatment group 5: Injection of HRS-9563 or placebo

EXPERIMENTAL

Drug: HRS-9563, placebo

Interventions

HRS-9563, placebo DRUG

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

Treatment group 1: Injection of HRS-9563 or placebo; Treatment group 2: Injection of HRS-9563 or placebo; Treatment group 3: Injection of HRS-9563 or placebo; Treatment group 4: Injection of HRS-9563 or placebo; Treatment group 5: Injection of HRS-9563 or placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Abnormal daily life rhythm;
• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 314408, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 12, 2025
• Study Start: December 24, 2024
• Primary Completion: June 9, 2026
• Study Completion: June 9, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

CN (1)