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Not yet recruitingNCT07230145Updated Nov 17, 2025

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

A Phase 1 interventional study of SHR-4658 Injection. and SHR-4658 Placebo Injection in Heart Failure, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 48 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    SHR-4658 Group

    Drug: SHR-4658 Injection.

  • Placebo comparator
    SHR-4658 Placebo Group

    Drug: SHR-4658 Placebo Injection

Interventions

  • DrugSHR-4658 Injection.

    SHR-4658 injection.

  • DrugSHR-4658 Placebo Injection

    SHR-4658 placebo injection.

06

What researchers measure

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.

07

Study locations

1 site
  • Beijing Anzhen Hospital Capital Medical University
    Beijing, Beijing Municipality 100029, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07230145
Lead sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Nov 2025 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Nov 17, 2025

Study contacts

Miao Guo
Contact
miao.guo.mg19@hengrui.com
+86-0518-82342973
Shuai Jiang
Contact
shuai.jiang.sj5@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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