NCT06082323

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

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: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (estimated)
• Sponsor: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteer
• Hidradenitis Suppurativa
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	LT-002-158/Placebo oral tablet(s)	Single ascending dose escalation and multiple ascending dose escalation study followed by an evaluation of food effects on absorption Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-03-31
• Completion: 2025-06-01
• First posted: 2023-10-13
• Last updated: 2025-02-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study