Trial Details

Not Recruiting
Basic Information
Clinical ID c2323
Identifier NL-OMON51292
Trial Title 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. - LMT503 First-in-human SAD, MAD, and FE study
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory bowel disease long lasting inflammation of the digestive tract;10017969
Interventions In the table below shows the planned dose levels for each group. The doses after the first group can be adjusted based on the results of the previous group(s). For example because the study compound had more or less effect than was expected. However, the dose will not be lower than 50 mg and not higher than 900 mg. The dose for the next group will only be increased if the lower dose of the previous group was found to be well tolerated and in case of no objection by the Medical Research Ethics Committee. The study will be discontinued or the dose will be decreased if, in the opinion of the investigators, unacceptable side effects appear. Part A: Group 1 will receive LMT503 50 mg or placebo on day 1, once daily after fasting. Group 2 will receive LMT503 150 mg or placebo on day 1, once daily after fasting. Group 3 will receive LMT503 300 mg or placebo on day 1, once daily after fasting. will receive LMT503 300 mg or placebo on day 1#, once daily after being fed (high fat breakfast). Group 4 will receive LMT503 600 mg or placebo on day 1, once daily after fasting. Group 5 will receive LMT503 XXX mg$ or placebo on day 1, once daily after fasting. Group 6 will receive LMT503 XXX mg$ or placebo on day 1, once daily after fasting. * If the amount will be higher or lower than planned, we will inform the volunteers. # Day 1 of the second period of stay. $ The dose is determined during the study and based on the results of the previous groups. Part B: Group 1 will receive LMT503 150 mg or placebo on days 1 to 7, once daily after fasting or being fed. Group 2 will receive 300 mg of LMT503 or placebo on days 1 to 7, once daily after fasting or b
Participant Information
Sponsor Lmito Therapeutics Inc.
City -
Country/Region Netherlands
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -