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

Beijing Suncadia Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Heart Failure

Treatments: Drug: SHR-4658 Injection.; Drug: SHR-4658 Placebo Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230145

SHR-4658-101

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

SHR-4658 Group

Experimental group

Treatment:

Drug: SHR-4658 Injection.

SHR-4658 Placebo Group

Placebo Comparator group

Treatment:

Drug: SHR-4658 Placebo Injection