Phase I Study of QLS12010 Capsules to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects in Healthy Adults and Adults with Moderate to Severe Atopic Dermatitis

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of QLS12010 Capsules in healthy adults and adults with moderate to severe atopic dermatitis AD. The study also examines how food affects the drugs PK profile. This Phase I clinical trial includes participants aged 18 to 75 and aims to gather early data on the drugs behavior and effects in these groups. The study consists of four parts Part A tests single ascending doses of QLS12010 or placebo in healthy volunteers. Part B involves multiple ascending doses over 14 days, with dosing determined based on Part A results. Part C is a randomized, open-label, two-cycle crossover study assessing the effect of food by giving doses under fasting and high-fat meal conditions. Part D evaluates safety, tolerability, PK, PD, and preliminary efficacy of multiple doses in adults with moderate to severe AD, divided into two dose groups. Participants will undergo screening and receive assigned doses of QLS12010 or placebo according to their group. Researchers will monitor treatment-related adverse events, measure drug levels in the blood, and assess skin condition using tools like the Eczema Area and Severity Index EASI, Investigators Global Assessment IGA, Peak Pruritus Numerical Rating Scale PP NRS, and body surface area affected. The study includes follow-ups of up to six weeks for AD patients and approximately one month for healthy volunteers to evaluate safety and drug effects.

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