A Phase I Study of QLS12010 Capsules in Healthy Adults

Phase 1

Recruiting

• Conditions: Atopic Dermatitis; Hidradenitis Suppurativa (HS); Rheumatoid Arthritis (RA)
• Interventions: Drug: QLS12010; Drug: Placebo

• Registration Number: NCT06946641
• Lead Sponsor: Shanghai Qilu Pharmaceutical Research and Development Center LTD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-30
• Study Start: 2025-03-31
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-26
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single ascending dose cohorts in healthy participants	QLS12010	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.
Single ascending dose cohorts in healthy participants	Placebo	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.
Multiple ascending dose cohorts in healthy subjects	QLS12010	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.
Multiple ascending dose cohorts in healthy subjects	Placebo	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.
Food Effect Cohort in healthy subjects	QLS12010	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.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0	up to approximately 1 month

Secondary Outcome Measures

Name	Time	Method
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]	up to approximately 1 month
Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]	up to approximately 14 days
Maximum observed plasma concentration (Cmax)	up to approximately 1 month
Time to maximum observed plasma concentration (Tmax)	up to approximately 1 month
Terminal elimination half-life (t1/2)	up to approximately 1 month
Apparent clearance (CL/F)	up to approximately 1 month
Apparent volume of distribution (Vz/F)	up to approximately 1 month
Mean residence time (MRT)	up to approximately 1 month

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China