A Trial of SHR-4658 in Healthy Volunteers or Volunteers W... | NCT07230145

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

NCT07230145

Sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Status

Not yet recruiting

Last Update Posted

Nov 17, 2025Actual

Enrollment

48Estimated

Phase

Phase 1

Conditions

Heart Failure

Interventions

SHR-4658 Injection.
SHR-4658 Placebo Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2025Estimated

Primary Completion Date

Jun 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Nov 13, 2025

First Submission Date that Met QC Criteria

Nov 13, 2025

First Posted Date

Nov 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SHR-4658 Group	Experimental		Drug: SHR-4658 Injection.
SHR-4658 Placebo Group	Placebo Comparator		Drug: SHR-4658 Placebo Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-4658 Injection.	Drug	SHR-4658 injection.	SHR-4658 Group
SHR-4658 Placebo Injection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve from time 0 to the last time point (AUC0-last)		Approximately 16 weeks.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)		Approximately 16 weeks.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital Capital Medical University		Beijing	Beijing Municipality	100029	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided