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New dermatitis drug candidate begins first human safety tests

NCT ID NCT07414602

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a single dose of the experimental drug SHR-1894 is safe and how it moves through the body. It involves 40 healthy adults aged 18 to 45. No treatment is given; the goal is to gather safety information before testing in patients with dermatitis.

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 40 people

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

Started

Mar 2026

Expected to finish

Dec 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 45 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. The subject has voluntarily provided written informed consent, fully understands the purpose and significance of this trial, and is willing to comply with the study protocol. 2. Healthy male or female subjects, aged 18 to 45 years (inclusive) at the time of signing the informed consent form. 3. Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height\^2 (m²). BMI between 19 and 26 kg/m², inclusive. 4. Subjects with no abnormalities, or only minor abnormalities deemed clinically insignificant by the investigator, in physical examination, vital signs, 12-lead electrocardiogram (ECG), posteroanterior and lateral chest radiographs, abdominal ultrasound, and laboratory tests during the screening and baseline periods. 5. Female subjects of childbearing potential and male subjects with partners of childbearing age must have been using highly effective contraception for at least 2 weeks prior to signing the informed consent form. They must be willing to either abstain from sexual intercourse or agree to continue using highly effective contraception from the time of signing the informed consent until the end of the follow-up period, and must have no plans for conception or donation of sperm/ova. Exclusion Criteria: 1. Subjects with a history or current diagnosis of any clinically significant disease, as determined by the investigator, involving the urinary, circulatory, endocrine, neurological, digestive, respiratory, hematopoietic, immune systems, or psychiatric and metabolic disorders. 2. Subjects who, in the investigator's judgment, have any condition or disease that may affect the absorption, metabolism, and/or excretion of the investigational drug. 3. Subjects who have experienced severe infection, severe trauma, or undergone major surgery within 1 month prior to the screening period; or who plan to undergo surgery during the trial period. 4. Subjects with a known allergy to the investigational drug or any of its components, or with a history of atopy (e.g., asthma, eczema). 5. Subjects will be excluded if they meet any of the following criteria: Use of any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, and vitamin A and its derivatives, with the exception of other routine vitamins and occasional use of acetaminophen) within 2 weeks prior to screening.Any medication taken within 5 half-lives prior to screening (whichever period is longer).Planned use of any non-study medication during the trial period. 6. Subjects will be excluded for any of the following: Participation in any other drug or medical device clinical trial within 3 months prior to screening or planned participation during the study period.Any prior investigational drug taken within 5 half-lives prior to screening (whichever washout period is longer). 7. Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test result at screening or baseline. 8. Subjects with a history of blood donation (≥ 400 mL) or significant blood loss within 8 weeks prior to screening, or who received a blood transfusion within 4 weeks prior to screening or baseline; or who intend to donate blood during the trial period. 9. Subjects who have received any vaccination within 2 weeks prior to screening or who plan to receive any vaccination during the trial. 10. Subjects with a history of significant smoking (averaging \>5 cigarettes per day) within 4 weeks prior to screening, or who are unable to abstain from using any tobacco products during the trial period. 11. Subjects meeting any of the following criteria will be excluded: Average daily alcohol intake exceeding 15 g (equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-alcohol spirits) within 4 weeks prior to screening.Inability to abstain from alcohol consumption during the trial period.A positive alcohol breath test at baseline. 12. Subjects with a history of illicit drug use or substance abuse/dependence prior to screening; or a positive urine drug test at baseline. 13. Subjects with special dietary requirements that prevent compliance with the standardized diet. 14. Subjects with difficult venous access or whose physical condition cannot tolerate frequent blood sampling.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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