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

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called IBI356 to see how safe it is and how well it works for people, including those with atopic dermatitis (a skin condition that causes itchy and inflamed skin). The study will involve both healthy individuals and patients with atopic dermatitis, and researchers want to learn about how the body processes this treatment and whether it can be tolerated well by participants.

To be eligible for the trial, healthy participants need to be between 18 and 45 years old and in good health, while those with atopic dermatitis should be between 18 and 75 years old and have had the condition for at least a year. Participants will be monitored closely during the study, and they will receive detailed information about what to expect throughout the process. This trial is currently recruiting participants, and it's important to note that individuals with certain health issues or recent treatments may not qualify. If you're interested in participating, please consult with your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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.