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

Sponsor
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Study ID
NCT06082323
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • LT-002-158/Placebo oral tablet(s) — DRUG
    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)

Study Details

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.

Key Dates

First listed
Oct 13, 2023
Start date
Jun 13, 2024
Status verified
Nov 2024
Primary completion
Mar 31, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
127 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Ascending Dose (SAD)
    Part 1: healthy volunteer subject cohorts randomized 6:2 receiving a single dose of LT-002-158 or placebo. The first cohort will receive 50mg of LT-002-158 or placebo. Dose escalation will occur if LT-002-158 or placebo is tolerated.
  • Experimental: Food effect
    Part 2: A 3-treatment, 3 period crossover study will be conducted, which is composed of 15 healthy Volunteer subjects, who will be receiving a single dose of LT-002-158 in fasted, standard meal and high fat meal.
  • Experimental: Multiple Ascending Doses (MAD) Study
    Part 3: Healthy volunteer subject cohorts randomized 8:2 to receive LT-002-158 or placebo for 14 days continuous dosing. The first cohort will receive a dose of LT-002-15 or placebo determined to be safe based on data generated in the SAD portion and FE study.

Primary Outcome Measure

To evaluate the safety and tolerability of LT-002-158 following single dose in HVs [ Time Frame: up to 28 days ]

Central Contacts

Find similar trials

Nationwide
Atopic dermatitis / eczema trialsHidradenitis suppurativa trialsDermatology trialsRheumatology trialsAutoimmune disease trials

Related Studies