RecruitingPhase 1NCT06946641

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Ascending Doses of QLS12010 Capsules in Healthy Adult Participants and Participants With Atopic Dermatitis


Sponsor

Shanghai Qilu Pharmaceutical Research and Development Center LTD

Enrollment

102 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called QLS12010 in healthy adults and in people with moderate-to-severe atopic dermatitis (eczema) to see how safe it is, how the body processes it, and whether food affects how it is absorbed. **You may be eligible if...** - You are between 18 and 45 years old (healthy volunteer part) or 18–75 (eczema part) - For the eczema part: you have had chronic atopic dermatitis for at least 6 months - For the eczema part: your eczema is moderate-to-severe (covering at least 10% of your body, with significant rash scores) - You have significant itch (itch score of 4 or higher on average) - Your weight meets the minimum requirement (50 kg for men, 45 kg for women) **You may NOT be eligible if...** - Your eczema has been well-controlled with current treatments - You have significant heart, liver, kidney, or immune system problems - You are pregnant or breastfeeding - You have recently used certain other eczema medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQLS12010

QLS12010 oral capsule(s)

DRUGPlacebo

Matching placebo oral capsule(s)


Locations(1)

Peking University Third Hospital

Beijing, China

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NCT06946641


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