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New rheumatoid arthritis drug candidate passes first safety check in healthy volunteers

NCT ID NCT06883695

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested the safety of a new drug called SHR-3045 in 40 healthy adults. The study was randomized, double-blind, and placebo-controlled, meaning some participants got the drug and some got a dummy shot. The main goal was to see if the drug causes any side effects and how the body processes it. This is a first step toward possibly treating rheumatoid arthritis, but much more research is needed.

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 drug proves safe and effective in future trials, it could become a new treatment option for rheumatoid arthritis.
What could go wrong
This is a very early phase 1 study in only 40 healthy people, not patients. It only looks at safety and how the drug moves through the body, not whether it works for arthritis. Many drugs fail in later stages.

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

40 people

The number who actually took part.

Started

Apr 2025

Finished

Oct 2025

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. 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

Contacts and locations

Locations

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

More trials for these conditions

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