New dermatitis drug candidate begins first human safety tests
NCT ID NCT07414602
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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