A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 heart-failure
Started Nov 2025
Shorter than P25 for phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2025
CompletedFirst Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
November 17, 2025
October 1, 2025
7 months
November 13, 2025
November 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
Approximately 16 weeks.
Secondary Outcomes (7)
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.
Maximum observed concentration (Cmax)
Approximately 16 weeks.
Time to maximum observed concentration (Tmax)
Approximately 16 weeks.
Apparent clearance (CL/F)
Approximately 16 weeks.
- +2 more secondary outcomes
Study Arms (2)
SHR-4658 Group
EXPERIMENTALSHR-4658 Placebo Group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 17, 2025
Study Start
November 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
November 17, 2025
Record last verified: 2025-10