A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis
NCT06931990 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-04-17
Summary
This study is an Ic/II phase clinical trial conducted in Chinese subjects with moderate to severe atopic dermatitis. The phase Ic study is a randomized, open label, parallel group design, mainly evaluating the safety and tolerability of LT-002-158 tablets in subjects with moderate to severe atopic dermatitis. The phase II study is a randomized, double-blind, placebo-controlled, parallel group design, with a single arm design for extended treatment, mainly exploring the efficacy of LT-002-158 tablets in the treatment of moderate to severe atopic dermatitis subjects.
Conditions
- Atopic Dermatitis (AD)
Interventions
- DRUG
-
LT-002-158 tablets
The subjects will orally administered LT-002-158 tablets once a day.
Sponsors & Collaborators
-
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-15
- Primary Completion
- 2025-10-30
- Completion
- 2025-12-30
- FDA Drug
- Yes
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