Inflammatory bowel disease long lasting inflammation of the digestive tract
Conditions
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
Sponsors
Lmito Therapeutics Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To assess the safety and tolerability of single and multiple ascending oral doses of LMT503 in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the pharmacokinetic (PK) profile of single and multiple ascending oral doses of LMT503 in healthy subjects. - To evaluate the effect of food on the safety and tolerability of LMT503 following a single oral dose of LMT503 in healthy subjects. - To assess the effect of food on the absorption and the PK profile of LMT503 following a single oral dose of LMT503 in healthy subjects. | — |
Countries
Netherlands
Outcome results
None listed