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New arthritis drug candidate SHR-3045 tested in healthy volunteers

NCT ID NCT07200596

Disease control Sponsor: Guangdong Hengrui Pharmaceutical 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 1 study tested a single injection of SHR-3045 in 16 healthy adults to see if it is safe and how the body processes it. The drug is being developed as a potential treatment for rheumatoid arthritis, an autoimmune disease that causes joint pain and swelling. Because this is a very early trial, it does not yet test whether the drug actually helps arthritis patients.

What this could mean

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

Active substance
SHR-3045
What this could lead to
If this early study shows SHR-3045 is safe, it could lead to larger trials testing whether it can help control rheumatoid arthritis.
What could go wrong
This is a very early Phase 1 trial with only 16 healthy people, not patients. It only checks safety and how the drug moves through the body, not whether it works for arthritis. Many drugs fail at this stage.

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

16 people

The number who actually took part.

Started

Oct 2025

Finished

Mar 2026

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. Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial. 2. Subjects who can provide written informed consent. 3. Males or females aged 18-55 years (both inclusive). 4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive). 5. No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests. Exclusion Criteria: 1. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening. 2. Known or suspected history of drug abuse. 3. Addiction to tobacco and alcohol. 4. Individuals who are unable to adhere to the dietary requirements of this trial during the study period. 5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

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

Rheumatoid arthritis (RA

Contacts and locations

Locations

  • The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230001, China

More trials for these conditions

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