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
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
102 participants
INTERVENTIONAL
2025-03-31
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Single ascending dose cohorts in healthy participants
Healthy volunteer subject cohorts randomized 6:2 receiving a single dose of QLS12010 or placebo. The starting dose will be 25 mg of QLS12010 or placebo.
QLS12010
QLS12010 oral capsule(s)
Placebo
Matching placebo oral capsule(s)
Multiple ascending dose cohorts in healthy subjects
Healthy volunteer subject cohorts randomized 8:2 to receive QLS12010 or placebo QD for 14 continuous days. The starting dose of QLS12010 or placebo is based on upcoming data from SAD part.
QLS12010
QLS12010 oral capsule(s)
Placebo
Matching placebo oral capsule(s)
Food Effect Cohort in healthy subjects
Part C is a two-cycle, crossover study under fasting and fed (high-fat meal) conditions. In Cycle 1, 12 healthy adult participants will be randomly divided into two groups on D-1, with 6 participants in each group receiving a single oral dose of QLS12010 Capsules under fasting or fed conditions, respectively. After completing washout, they will receive crossover administration for the Cycle 2 study.
QLS12010
QLS12010 oral capsule(s)
Early Efficacy in patients with AD
Part D of the study plans to enroll 12 adults with moderate to severe atopic dermatitis (AD). Eligible subjects (after screening) will be sequentially assigned to two dose groups (Dose 1 and Dose 2) in the order of their enrollment. Enrollment of Dose 2 may commence only after Dose 1 has completed enrollment of 6 subjects.
QLS12010
QLS12010 oral capsule(s)
Interventions
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QLS12010
QLS12010 oral capsule(s)
Placebo
Matching placebo oral capsule(s)
Eligibility Criteria
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Inclusion Criteria
* Weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI): 18.0-30.0 kg/m2 (inclusive),
* 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.
* Participants who smoke more than 5 cigarettes per day on average within 6 months before screening or are currently using e-cigarettes,
* Participants who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 6 months before screening or have a positive breath alcohol test at screening,
* Participants who have donated more than 400 mL of blood within 3 months or more than 200 mL of blood within 4 weeks before screening, or plan to donate blood during the study,
* Participants who have received any strong inhibitor or inducer of CYP3A4 within 4 weeks before screening,
* Participants who have received any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks before the first dose or 5 half-lives (whichever is longer).
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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Shanghai Qilu Pharmaceutical Research and Development Center LTD
INDUSTRY
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Wenhui Wang, M.D.
Role: backup
Other Identifiers
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QLS12010-101
Identifier Type: -
Identifier Source: org_study_id
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