NCT05659953

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LMT503 in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Lmito Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Inflammatory Bowel Disease
• Colitis, Ulcerative
• Crohn Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-10-01
• Completion: 2026-03-01
• First posted: 2022-12-21
• Last updated: 2024-10-23

Locations

1 site across 1 country: Netherlands