This phase I/IIa study will be composed of a Phase I study, which includes 14 days of treatment with AR100DP1 followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1 and a following single-arm Phase IIa study with 28 days of treatment followed by 2 weeks of follow-up period to evaluate the efficacy of AR100DP1 with the recommended Phase II dose (RP2D) in treating atopic dermatitis on target lesion. The target lesion is defined as ≤ 5% BSA (up to ~ 750 cm2) of AD patients. Eligible subjects will have target lesion area selected by the investigator and recorded for AR100DP1 topical administration before dosing. AR100DP1 should be topically administered on target lesions twice daily for 14 days in Phase I study whereas for 28 days in Phase IIa study.
This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Subjects with Atopic Dermatitis.