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

What this Trial Is About

Researchers are evaluating LT-002-158, an oral IRAK4 protein degrader being developed to treat autoimmune diseases and inflammation, including Hidradenitis Suppurativa and Atopic Dermatitis. This first-in-human Phase 1 study aims to assess the safety, tolerability, and how the drug is absorbed and processed in the body pharmacokinetics and pharmacodynamics in healthy adult volunteers. The study also examines how food intake affects the drugs absorption. The trial includes three parts Part 1 involves single ascending doses where groups of healthy volunteers receive either LT-002-158 or placebo, starting at 50 mg, with doses increasing if tolerated. Part 2 is a crossover study with healthy volunteers receiving a single dose of LT-002-158 under different food conditions fasted, standard meal, and high-fat meal to evaluate food effects. Part 3 involves multiple ascending doses given daily for 14 days, with dosing levels determined based on earlier safety and pharmacokinetic data. Participants will be closely monitored through physical exams, vital signs, ECGs, laboratory tests, and pregnancy tests for women. Researchers will track safety and how the drug behaves in the body up to 28 days after dosing. Volunteers must comply with scheduled visits and procedures throughout the study, which is expected to run until June 2025.

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