Actively Recruiting
A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of QLS12010 Capsules in Healthy Adults and Adults With Atopic Dermatitis
Led by Shanghai Qilu Pharmaceutical Research and Development Center LTD · Updated on 2025-07-31
102
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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 drug's PK profile. This Phase I clinical trial includes participants aged 18 to 75 and aims to gather early data on the drug's 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), Investigator's 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.
CONDITIONS
Brief 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 to 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
- Male or female participants aged 18 to 75 years for Part D
- Chronic atopic dermatitis diagnosed by Hannifin and Rajka criteria for at least 6 months before screening
- Eczema Area and Severity Index (EASI) score of 16 or higher at screening and baseline
- Investigator's Global Assessment (vIGA-AD) score of 3 or higher at screening and baseline
- Body surface area (BSA) affected by atopic dermatitis of 10% or more
- Weekly mean Peak Pruritus Numerical Rating Scale (PP NRS) score of 4 or higher prior to first administration
- Inadequate response to topical medication therapy within 6 months before screening as judged by the investigator
You will not qualify if you...
- Presence of diseases affecting nervous, psychiatric, cardiovascular, blood, immune, respiratory, digestive, urinary, metabolic, or skeletal systems as judged at screening
- QTcF (corrected QT interval) greater than 450 ms on 12-lead ECG at screening
- Smoking more than 5 cigarettes per day on average within 6 months before screening or current use of e-cigarettes
- Consuming more than 14 units of alcohol per week within 6 months before screening or positive breath alcohol test at screening
- Donating more than 400 mL of blood within 3 months or more than 200 mL within 4 weeks before screening, or planning to donate blood during the study
- Use of strong inhibitors or inducers of CYP3A4 within 4 weeks before screening
- Use of prescription drugs, over-the-counter drugs, traditional medicines, or dietary supplements within 2 weeks before the first dose or 5 half-lives (whichever is longer)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks depending on cohort
Participants receive QLS12010 or placebo capsules as part of different dosing cohorts including single ascending dose, multiple ascending dose, food effect, and early efficacy in atopic dermatitis patients.
Varies: single dose or daily dosing for 14 days; crossover dosing with washout in food effect cohort; weekly visits for up to 6 weeks in atopic dermatitis patients
Duration - Up to approximately 1 month
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and changes in atopic dermatitis symptoms after treatment.
Weekly visits for up to 6 weeks in atopic dermatitis patients; additional visits as needed for safety assessments
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
H
Haiyan Li, M.D.
W
Wenhui Wang, M.D.
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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