A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients

NCT06946641 | Recruiting Phase 1

• 1 other identifier: QLS12010-101
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Atopic Dermatitis; Hidradenitis Suppurativa (HS); Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0

  up to approximately 1 month

Secondary Outcomes (12)

• 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

Study Arms (4)

Single ascending dose cohorts in healthy participants

EXPERIMENTAL

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.

Drug: QLS12010; Drug: Placebo

Multiple ascending dose cohorts in healthy subjects

EXPERIMENTAL

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.

Drug: QLS12010; Drug: Placebo

Food Effect Cohort in healthy subjects

EXPERIMENTAL

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.

Drug: QLS12010

Early Efficacy in patients with AD

EXPERIMENTAL

Part D of the study plans to enroll 12 adults with moderate to severe atopic dermatitis (AD). Eligible subjects (after screening) will be sequentially assigned to two dose groups (Dose 1 and Dose 2) in the order of their enrollment. Enrollment of Dose 2 may commence only after Dose 1 has completed enrollment of 6 subjects.

Drug: QLS12010

Interventions

QLS12010 DRUG

QLS12010 oral capsule(s)

Early Efficacy in patients with AD; Food Effect Cohort in healthy subjects; Multiple ascending dose cohorts in healthy subjects; Single ascending dose cohorts in healthy participants

Placebo DRUG

Matching placebo oral capsule(s)

Multiple ascending dose cohorts in healthy subjects; Single ascending dose cohorts in healthy participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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).

Sponsors & Collaborators

• Shanghai Qilu Pharmaceutical Research and Development Center LTD: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Hidradenitis Suppurativa; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases

Central Study Contacts

Haiyan Li, M.D.

CONTACT

(+86) 18600489179; haiyanli1027@hotmail.com

Wenhui Wang, M.D.

CONTACT

(+86) 15611908751; wwh0608@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 27, 2025
• Study Start: March 31, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CN (1)