A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-4658 Injection., SHR-4658 Placebo Injection.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug SHR-4658 Injection.
SHR-4658 injection. - Drug SHR-4658 Placebo Injection
SHR-4658 placebo injection.
Primary outcome measures
- Adverse events (AEs) [Time frame: Approximately 16 weeks.]
Secondary outcome measures (7)
- Area under the concentration-time curve from time 0 to the last time point (AUC0-last) [Time frame: Approximately 16 weeks.]
- Area under the concentration-time curve from time 0 to infinity (AUC0-inf) [Time frame: Approximately 16 weeks.]
- Maximum observed concentration (Cmax) [Time frame: Approximately 16 weeks.]
- Time to maximum observed concentration (Tmax) [Time frame: Approximately 16 weeks.]
- Apparent clearance (CL/F) [Time frame: Approximately 16 weeks.]
- Apparent volume of distribution (Vd/F) [Time frame: Approximately 16 weeks.]
- Terminal elimination half-life (t1/2) [Time frame: Approximately 16 weeks.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anzhen Hospital Capital Medical University — Beijing
Identifiers
NCT: NCT07230145 · SHR-4658-101