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.
- Conditions
- Inflammatory bowel diseaselong lasting inflammation of the digestive tract10017969
- Registration Number
- NL-OMON51292
- Lead Sponsor
- mito Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
1. Sex : male or female.
2. Age : 18 to 65 years, inclusive, at screening.
3. Body mass index : 18.0 to 30.0 kg/m2, inclusive, at screening.
4. Weight : 50 to 110 kg, inclusive, at screening.
5. Status : healthy subjects.
Further criteria apply, see protocol.
Exclusion Criteria
1. Previous participation in the current study.
2. Employee of PRA or the Sponsor.
3. History of relevant drug and/or food allergies.
4. Using tobacco products within 2 months prior to (first) admission.
5. History of alcohol abuse or drug addiction (including soft drugs like
cannabis products).
Further criteria apply, see protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To assess the safety and tolerability of single and multiple ascending oral<br /><br>doses of LMT503 in healthy subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the pharmacokinetic (PK) profile of single and multiple ascending<br /><br>oral doses of LMT503 in healthy subjects.<br /><br>- To evaluate the effect of food on the safety and tolerability of LMT503<br /><br>following a single oral dose of LMT503 in healthy subjects.<br /><br>- To assess the effect of food on the absorption and the PK profile of LMT503<br /><br>following a single oral dose of LMT503 in healthy subjects.</p><br>