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

Name: LMT503 First-in-human SAD, MAD, and FE Study — clinical trial record (NCT05659953)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 1

SponsorLmito Therapeutics Inc.

Started2027-03-01

View on ClinicalTrials.gov ↗

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.

Amendment history 2 changes detected by DataLookout

2026-09-02

Primary completion pushed: 2025-10-01 → 2027-09-01

2026-09-02

Completion pushed: 2026-03-01 → 2027-12-01

Trial Details

NCT Number	NCT05659953
Lead Sponsor	Lmito Therapeutics Inc.
Conditions	Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease
Enrollment	72 participants
Start Date	2027-03-01
Primary Completion	2027-09-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-09-01