Status:
COMPLETED
A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Healthy Participants
Atopic Dermatitis Patients
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
Eligibility Criteria
Inclusion
- Healthy participants:
- Aged 18 to 45 years,
- Weight 50 to 120 kgs,
- Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- No child-bearing potential during the trial and within 6 months after SAD doses, and adequate contraceptive measures can be taken.
- Atopic dermatitis:
- Aged 18 to 75 years,
- body mass index (BMI): 18.0 - 32.0 kg/m2,
- Atopic Dermatitis (AD) for 1 year or longer at Baseline,
- Eczema Area and Severity Index (EASI) of 16 or higher at baseline,
- Investigator Global Assessment (IGA) of 3 or 4 at baseline,
- AD involvement of 10 percent or more of body surface area at Baseline,
- Documented history, within 1 year before Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments,
- Must have applied a stable dose of topical bland emollient at least twice daily for at least 7 consecutive days before Baseline.
Exclusion
- History of relevant drug allergies.
- 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
- Healthy participants:
- History of alcohol abuse or drug addiction within 1 year before screen,
- Positive drug and alcohol screen at screening.
- Atopic dermatitis:
- 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:
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2025
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06193434
Start Date
January 5 2024
End Date
August 20 2025
Last Update
September 2 2025
Active Locations (1)
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1
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China, 200443