Heart FailurePhase 1NCT07230145
A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure
A Phase 1 study testing SHR-4658 Injection. in people with Heart Failure, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- SHR-4658 Injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Nov 2025to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, 100029
Yang Lin, +86-010-64456045, linyang@anzhengcp.com
Shan Jing, +86-010-64456014, jingshan@anzhengcp.com
About this study
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
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.
- Conditions
- Heart Failure
- Being tested
- SHR-4658 Injection., SHR-4658 Placebo Injection
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4658 Injection.Drug
SHR-4658 injection.
SHR-4658 Placebo InjectionDrug
SHR-4658 placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-4658 Group | Experimental | Not described Receives: Drug: SHR-4658 Injection. |
| SHR-4658 Placebo Group | Placebo comparator | Not described Receives: Drug: SHR-4658 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Approximately 16 weeks.
Secondary outcomes (7)
Area under the concentration-time curve from time 0 to the last time point (AUC0-last)
Measured: Approximately 16 weeks.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: Approximately 16 weeks.
Maximum observed concentration (Cmax)
Measured: Approximately 16 weeks.
Time to maximum observed concentration (Tmax)
Measured: Approximately 16 weeks.
Apparent clearance (CL/F)
Measured: Approximately 16 weeks.
Apparent volume of distribution (Vd/F)
Measured: Approximately 16 weeks.
Terminal elimination half-life (t1/2)
Measured: Approximately 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230145
- Sponsor's protocol ID
- SHR-4658-101
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07230145
- Acronym / sponsor ID
- SHR-4658-101
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-4658 Group | Experimental | Drug: SHR-4658 Injection. |
| SHR-4658 Placebo Group | Placebo comparator | Drug: SHR-4658 Placebo Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-4658 Injection.SHR-4658 injection. | Drug | SHR-4658 Group |
| SHR-4658 Placebo InjectionSHR-4658 placebo injection. | Drug | SHR-4658 Placebo Group |
Primary outcome
Adverse events (AEs)
Time frame: Approximately 16 weeks.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-4658 Injection. in people with Heart Failure, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miao Guo (+86-0518-82342973, miao.guo.mg19@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Approximately 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.