A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients

Korábbi kezelés

• 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.

Más betegség

• 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.

• 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.