A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure

November 13, 2025 updated by: Beijing Suncadia Pharmaceuticals Co., Ltd

A Double-Blind, Randomized, Dose-Escalating Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure

This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of single subcutaneous injection of SHR-4658 in healthy volunteers and volunteers with elevated blood pressure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Beijing Anzhen Hospital Capital Medical University
        • Principal Investigator:
          • Yang Lin
        • Principal Investigator:
          • Shan Jing
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent.
  2. Blood pressure as defined in the protocol.
  3. Male or female，aged 18 to 55 years (inclusive).
  4. Meet the weight standard.

Exclusion Criteria:

  1. Known history or current clinically significant disease.
  2. Protocol-defined risk factors for disease.
  3. Participated in clinical trials of other drugs or medical devices.
  4. Pregnant or nursing women.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-4658 Group
Drug: SHR-4658 Injection.
SHR-4658 injection.
Placebo Comparator: SHR-4658 Placebo Group
Drug: SHR-4658 Placebo Injection
SHR-4658 placebo injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve from time 0 to the last time point (AUC0-last)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.
Maximum observed concentration (Cmax)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.
Time to maximum observed concentration (Tmax)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.
Apparent clearance (CL/F)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.
Apparent volume of distribution (Vd/F)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.
Terminal elimination half-life (t1/2)
Time Frame: Approximately 16 weeks.
Approximately 16 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-4658-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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