NCT06931990

A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis

A Phase Ic/II Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	LT-002-158 tablets	The subjects will orally administered LT-002-158 tablets once a day.

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-10-30
• Completion: 2025-12-30
• First posted: 2025-04-17
• Last updated: 2025-04-17

Regulatory

• FDA-regulated drug study