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NCT06946641RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
102 (estimated)
First submitted
30 Mar 2025
Start date
31 Mar 2025
Primary completion date
31 Dec 2025
Lead sponsor
Shanghai Qilu Pharmaceutical Research and Development Center LTD
NCT number
NCT06946641

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 102
  • From 31 Mar 2025 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Males and females aged 18-45 (inclusive),
  • 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.
    • General Exclusion Criteria:
  • Participants with diseases that should be excluded as judged by the investigator at screening, including but not limited to the nervous system, psychiatric system, cardiovascular system, blood and lymphatic system, immune system, respiratory system, digestive system, urinary system, metabolic and skeletal system disorders,
  • The 12-lead ECG at screening shows QTcF (QT corrected using Fridericia's formula) \> 450 ms. If QTcF is \> 450 ms, the 12-lead ECG should be repeated 2 more times (at least 3 min apart), and the mean of the 3 measurements will be used to determine whether the participant meets the inclusion criteria,
  • 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).
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University Third Hospital
Coordinator of this site? Confirm its status		BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.