Clinical Trial

A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers

Recruiting Phase 1
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Record status
This record was last updated February 19, 2025 (before its estimated March 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
LT-002-158 is an oral IRAK4 protein degrader being developed for the treatment of autoimmune disease and inflammation including Hidradenitis Suppurativa and Atopic Dermatitis. This first-in-human (FIH) study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of LT-002-158 in healthy volunteers. The effects of food on the pharmacokinetics of LT-002-158 will also be assessed in healthy volunteers.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-09; most recent amendment 2025-02-16.
Status change: Not Yet Recruiting → Recruiting 2024-11-15
Trial Details
NCT Number NCT06082323
Lead Sponsor Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Conditions Healthy Volunteer, Hidradenitis Suppurativa, Atopic Dermatitis
Enrollment 127 participants
Start Date 2024-06-13
Primary Completion 2025-03-31 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-19