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NCT Number: NCT07230145

A Trial of 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SHR-4658 Injection.

Drug

SHR-4658 injection.

SHR-4658 Placebo Injection

Drug

SHR-4658 placebo injection.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Approximately 16 weeks.

Secondary outcomes

  1. Area under the concentration-time curve from time 0 to the last time point (AUC0-last)

    Time frame: Approximately 16 weeks.

  2. Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

    Time frame: Approximately 16 weeks.

  3. Maximum observed concentration (Cmax)

    Time frame: Approximately 16 weeks.

  4. Time to maximum observed concentration (Tmax)

    Time frame: Approximately 16 weeks.

  5. Apparent clearance (CL/F)

    Time frame: Approximately 16 weeks.

  6. Apparent volume of distribution (Vd/F)

    Time frame: Approximately 16 weeks.

  7. Terminal elimination half-life (t1/2)

    Time frame: Approximately 16 weeks.

Study contacts

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

Miao Guo

CONTACT

[email protected]

+86-0518-82342973

Shuai Jiang

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Nov 17, 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.

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