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

NCT ID: NCT07230145

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-4658 Group

Group Type EXPERIMENTAL

SHR-4658 Injection.

Intervention Type DRUG

SHR-4658 injection.

SHR-4658 Placebo Group

Group Type PLACEBO_COMPARATOR

SHR-4658 Placebo Injection

Intervention Type DRUG

SHR-4658 placebo injection.

Interventions

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SHR-4658 Injection.

SHR-4658 injection.

Intervention Type DRUG

SHR-4658 Placebo Injection

SHR-4658 placebo injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Miao Guo

Role: CONTACT

+86-0518-82342973

Shuai Jiang

Role: CONTACT

+86-0518-82342973

Facility Contacts

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Yang Lin

Role: primary

+86-010-64456045

Shan Jing

Role: backup

+86-010-64456014

Other Identifiers

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SHR-4658-101

Identifier Type: -

Identifier Source: org_study_id

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