Phase
Condition
Allergies & Asthma
Eczema (Atopic Dermatitis - Pediatric)
Skin Wounds
Treatment
IBI356 for SAD
Placebo for MAD
Placebo for SAD
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 SADdoses, 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 inadequateresponse to topical treatments or inadvisability of topical treatments,
Must have applied a stable dose of topical bland emollient at least twice dailyfor at least 7 consecutive days before Baseline.
Exclusion
Exclusion Criteria:
History of relevant drug allergies.
Has any condition that, in the opinion of the investigator, would make participationnot be in the best interest (for example, compromise the well-being) of theparticipant or that could prevent, limit, or confound the protocol-specifiedassessments
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 baselinevisit, or any condition that, in the opinion of the investigator, was likely torequire 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.
Study Design
Connect with a study center
Shanghai Skin Disease Hospital
Shanghai, Shanghai 200443
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.