NCT06946641 A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients
| NCT ID | NCT06946641 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Qilu Pharmaceutical Research and Development Center LTD |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2025-12 |
Trial Parameters
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria for Parts A-C: * Males and females aged 18-45 (inclusive), * Weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI): 18.0-30.0 kg/m2 (inclusive), Inclusion Criteria for Part D: * Female or male participants between the ages of 18 to 75 years of age. * Chronic AD diagnosed by the criteria of Hannifin and Rajka that has been present for at least 6 Months before the Screening Visit. * At screening and baseline: EASI score ≥ 16, vIGA-AD™ score ≥ 3, and BSA affected by AD ≥ 10%; * The weekly mean score of PP NRS ≥ 4 prior to the first administration (with assessment results for at least 4 days during the week before the first administration \[D-7 to D-1\]); * As judged by the investigator, within 6 months prior to screening, the patient had an inadequate response to topical medication therapy. General Exclusion Criteria: * Participants with diseases that should be excluded as judged by the investigator at screening, including but not limited to the nervo
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