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LMT503 First-in-human SAD, MAD, and FE Study

NCT05659953 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-10-23

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part with integrated food effect (FE) arm, and a multiple ascending dose (MAD) part to assess the safety, tolerability, and PK of ascending single and multiple oral doses of LMT503. The study will start with the SAD part.

Conditions

Interventions

DRUG

LMT503

Subjects will receive one of several different oral doses of LMT503 once daily

DRUG

Placebo

Subjects will receive one of several different oral doses of Placebo once daily

Sponsors & Collaborators

  • Lmito Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Wheeseong LEE, PhD · Lmito Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-10-01
Completion
2026-03-01

Countries

  • Netherlands

Study Locations

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Entities

Drugs
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 NCT05659953 on ClinicalTrials.gov