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New eczema drug candidate passes first safety hurdle in small trial
NCT ID NCT06193434
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-stage trial tested an experimental drug called IBI356 in 99 healthy volunteers and people with atopic dermatitis (eczema). The main goal was to check if the drug is safe and how the body processes it. Participants received either a single dose, multiple doses, or a placebo. Results will help decide whether to move to larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI356 (an experimental drug given as an infusion)
- What this could lead to
- If this early trial shows IBI356 is safe, it could lead to larger studies testing whether it helps control atopic dermatitis (eczema) symptoms.
- What could go wrong
- This is a very early Phase 1 study focused on safety, not on whether the drug works. Many drugs fail in later stages, so it is far too soon to know if IBI356 will be effective.
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
-
99 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
-
Aug 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 70 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Healthy participants: 1. Aged 18 to 45 years, 2. Weight 50 to 120 kgs, 3. Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator. 4. No child-bearing potential during the trial and within 6 months after SAD doses, and adequate contraceptive measures can be taken. 2. Atopic dermatitis: 1. Aged 18 to 75 years, 2. body mass index (BMI): 18.0 - 32.0 kg/m2, 3. Atopic Dermatitis (AD) for 1 year or longer at Baseline, 4. Eczema Area and Severity Index (EASI) of 16 or higher at baseline, 5. Investigator Global Assessment (IGA) of 3 or 4 at baseline, 6. AD involvement of 10 percent or more of body surface area at Baseline, 7. Documented history, within 1 year before Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments, 8. Must have applied a stable dose of topical bland emollient at least twice daily for at least 7 consecutive days before Baseline. Exclusion Criteria: 1. History of relevant drug allergies. 2. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments 3. Healthy participants: 1. History of alcohol abuse or drug addiction within 1 year before screen, 2. Positive drug and alcohol screen at screening. 4. Atopic dermatitis: 1. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require Immunosuppressive/ immunomodulating drugs treatment(s) during the first 4 weeks of study treatment: 2. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.
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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.
Contacts and locations
Locations
-
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
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