A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients

The goal of this clinical trial is to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of QLS12010 Capsules and the effect of food on their PK profiles in healthy adult participants and participants with atopic dermatitis. This study consists of four parts: Part A is a single ascending dose (SAD) study, once sufficient safety and PK data are obtained from the SAD cohorts, the SMC will determine the dosage of initial cohort in Part B, which consists of three multiple ascending doses (MAD) cohorts of QLS12010 Capsules. Part C is a randomized, open-label, two-cycle, crossover food effect study under fasting and fed (high-fat meal) conditions. Part D is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and preliminary efficacy of QLS12010 Capsules following multiple oral administrations in adult participants with atopic dermatitis (AD).

NCT Number	NCT06946641
Lead Sponsor	Shanghai Qilu Pharmaceutical Research and Development Center LTD
Conditions	Atopic Dermatitis, Hidradenitis Suppurativa (HS), Rheumatoid Arthritis (RA)
Enrollment	102 participants
Start Date	2025-03-31
Primary Completion	2025-12 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2025-07-31