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New psoriasis drug SHR-1139 enters first human trials

NCT ID NCT07051538

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-stage trial tests a new drug called SHR-1139 in healthy volunteers and people with moderate-to-severe plaque psoriasis. The main goal is to check safety and how the body handles the drug. A total of 64 participants will receive either the drug or a placebo, with doses given as injections under the skin or into a vein.

What this could mean

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

Active substance
SHR-1139 injection
What this could lead to
If successful, this could lead to a new treatment option for moderate-to-severe plaque psoriasis, potentially offering better disease control.
What could go wrong
This is an early Phase 1 trial with only 64 participants, focused on safety and dosing. It is too small and early to know if the drug will effectively treat psoriasis or have serious side effects.

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

64 people

The number who actually took part.

Started

Jun 2024

Finished

Nov 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 65 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 who fully understand the trial procedures, voluntarily agree to participate, and sign a written informed consent form. 2. Age between 18 and 55 years old (inclusive). 3. Vital signs, physical examinations, laboratory tests, and other assessments are normal or show abnormalities without clinical significance. Exclusion Criteria: 1. Subjects with any clinical disease in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric systems, or metabolic abnormalities; or any other disease that may interfere with trial results. 2. History of malignant tumor. 3. Opportunistic infection within 6 months prior to screening. 4. Acute infection with systemic symptoms requiring systemic intravenous or oral anti-infective treatment within 4 weeks before baseline. 5. Participation in any drug or medical device clinical trial within 3 months prior to screening.

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

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

Moderate to severe plaque psoriasis

Contacts and locations

Locations

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200031, China

More trials for these conditions

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