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New eczema drug candidate passes first safety hurdle in small trial

NCT ID NCT06193434

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

More trials for these conditions

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