A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
NCT ID: NCT06193434
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
99 participants
INTERVENTIONAL
2024-01-05
2025-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IBI356 for Single ascending dose (SAD)
IBI356 for SAD
Receive IBI356 in a single dose.
IBI356 for Multiple ascending dose (MAD)
IBI356 for MAD
Receive IBI356 in a multiple dose.
Placebo for MAD
Placebo for MAD
Receive placebo in a multiple dose.
Dupilumab for MAD
Dupilumab for MAD
Active comparator
Placebo for SAD
Placebo for SAD
Receive placebo in a single dose.
Interventions
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IBI356 for MAD
Receive IBI356 in a multiple dose.
Dupilumab for MAD
Active comparator
IBI356 for SAD
Receive IBI356 in a single dose.
Placebo for SAD
Receive placebo in a single dose.
Placebo for MAD
Receive placebo in a multiple dose.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CIBI356A101CN
Identifier Type: -
Identifier Source: org_study_id
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