Actively Recruiting
A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients
Led by Shanghai Qilu Pharmaceutical Research and Development Center LTD · Updated on 2025-07-31
102
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18-45 years for Parts A-C
- Weight of at least 50 kg for males and 45 kg for females
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 for Parts A-C
- Female or male participants aged 18 to 75 years for Part D
- Chronic atopic dermatitis diagnosed by Hannifin and Rajka criteria present for at least 6 months before screening for Part D
- At screening and baseline, EASI score of 16 or higher, vIGA-AD13 score of 3 or higher, and body surface area (BSA) affected by AD of 10% or more for Part D
- Weekly mean score of pruritus numeric rating scale (PP NRS) of 4 or higher prior to first administration with assessment for at least 4 days during the week before dosing for Part D
- Inadequate response to topical medication therapy within 6 months prior to screening as judged by the investigator for Part D
You will not qualify if you...
- Presence of diseases affecting the nervous, psychiatric, cardiovascular, blood and lymphatic, immune, respiratory, digestive, urinary, metabolic, or skeletal systems as judged by the investigator
- QTcF (QT corrected using Fridericia's formula) greater than 450 ms on 12-lead ECG at screening
- Smoking more than 5 cigarettes per day or current use of e-cigarettes within 6 months before screening
- Consumption of more than 14 units of alcohol per week within 6 months before screening or positive breath alcohol test at screening
- Donation of more than 400 mL of blood within 3 months or more than 200 mL within 4 weeks before screening, or plans to donate blood during the study
- Use of any strong inhibitor or inducer of CYP3A4 within 4 weeks before screening
- Use of prescription drugs, over-the-counter drugs, traditional medicines, or dietary supplements within 2 weeks before first dose or 5 half-lives (whichever is longer)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
H
Haiyan Li, M.D.
CONTACT
W
Wenhui Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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