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

Atopic Dermatitis Clinical Trial

Official title: A Phase 1，Randomized, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered LT-002-158 in Healthy Adult Volunteers

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This is a first-in-human (FIH), Phase 1 randomized, placebo-controlled, single and multiple ascending dose trial of LT-002-158 that will characterize the safety, PK and PD of orally administered LT-002-158 after a single dose (Part 1) and after repeated dosing in healthy adult volunteers (Part 3). A 3 treatment, 3-periods crossover design is planned on healthy subjects to understand food effects (FE) on the PK of LT-002-158 (Part 2). Once adequate safety and PK data from multiple SAD cohorts and FE cohort become available, a safe starting dose for the 14-day MAD portion of the study will be selected so as to initiate the enrolment of healthy subjects into 14-day multiple ascending dose (MAD) escalation cohorts. ;

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Healthy Volunteer
• Hidradenitis
• Hidradenitis Suppurativa

• NCT number: NCT06082323
• Study type: Interventional
• Source: Shanghai Leadingtac Pharmaceutical Co., Ltd.
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 13, 2024
• Completion date: March 10, 2025