Clinical trial NCT06946641: A Phase I Study of QLS12010 Capsules in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Atopic Dermatitis
Hidradenitis Suppurativa (HS)
Rheumatoid Arthritis (RA)
Lead sponsor: Shanghai Qilu Pharmaceutical Research and Development Center LTD
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. This study consists of three 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.


Eligibility criteria: Inclusion Criteria:

* 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),

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 CYP3A4within 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).

Primary outcomes:
measure: Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
timeFrame: up to approximately 1 month
Secondary outcomes:
measure: Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
timeFrame: up to approximately 1 month
measure: Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]
timeFrame: up to approximately 14 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: up to approximately 1 month
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: up to approximately 1 month
measure: Terminal elimination half-life (t1/2)
timeFrame: up to approximately 1 month
measure: Apparent clearance (CL/F)
timeFrame: up to approximately 1 month
measure: Apparent volume of distribution (Vz/F)
timeFrame: up to approximately 1 month
measure: Mean residence time (MRT)
timeFrame: up to approximately 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: