Testing QLS12010 Capsules in Healthy Adults
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
This study is testing if QLS12010 Capsules are safe and how well they are tolerated by healthy adults while also looking at how food affects the way the body absorbs the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Qilu Pharmaceutical Research and Development Center LTD Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06946641 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18-45 with a BMI between 18.0 and 30.0.
Not a fit: Patients with significant underlying health conditions or those who smoke heavily may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of QLS12010's safety profile, potentially paving the way for its use in treating conditions like atopic dermatitis and rheumatoid arthritis.
How similar studies have performed: While this approach is not widely tested, similar studies evaluating new drug candidates in healthy populations have shown promise in establishing safety and dosing parameters.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Haiyan Li, M.D.
- Email: haiyanli1027@hotmail.com
- Phone: (+86) 18600489179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.