RecruitingPhase 1NCT06082323

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

Sponsor

Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

Enrollment

127 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer Atopic Dermatitis Hidradenitis Suppurativa

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LT-002-158/Placebo oral tablet(s) for people with atopic dermatitis, healthy volunteer, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLT-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)