Testing QLS12010 Capsules in Healthy Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of QLS12010 Capsules in healthy adults through a phased approach. It consists of three parts: a single ascending dose study, followed by multiple ascending doses, and a crossover study to assess the effect of food on drug absorption. Participants will receive either the active drug or a placebo, and their responses will be monitored to gather pharmacokinetic and pharmacodynamic data.

Why it matters

Who can join: the full rules

Inclusion Criteria for Parts A-C:

* 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),

Inclusion Criteria for Part D:

* 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.

Where it's running

• Peking University Third Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Haiyan Li, M.D.
• Email: haiyanli1027@hotmail.com
• Phone: (+86) 18600489179

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.