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New heart failure drug SHR-4658 enters first human safety trial

NCT ID NCT07230145

Disease control Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a single injection of SHR-4658 in 48 healthy volunteers and people with slightly high blood pressure. The main goal is to check safety and how the body processes the drug. If it passes safety checks, it may lead to larger studies for heart failure treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-4658 injection
What this could lead to
If successful, this could point toward a new treatment option for heart failure by controlling blood pressure.
What could go wrong
This is an early Phase 1 trial with only 48 participants, focused on safety and dosing. It is too small and early to know if SHR-4658 will effectively treat heart failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

heart failure hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital Capital Medical University

    Beijing, Beijing Municipality, 100029, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.