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

NCT06082323 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qian Chen, MD · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2025-03-31
Completion
2025-06-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082323 on ClinicalTrials.gov