Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT06193434
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06193434
Study Brief:
Protocol Section:
NCT06193434