A Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
MDI Therapeutics, Inc.
Summary
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants. Healthy participants will take single or multiple doses of drug and the safety and drug levels will be measured.
Description
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants. Healthy participants will take single or multiple doses of drug and the safety and drug levels will be measured. Healthy participants will be monitored for adverse events, laboratory test changes, changes in vital signs, electrocardiogram and the plasma drug levels will be measured. The amount of the drug and its metabolites in urine and blood will be measured. Blood and urine will be used to evaluate the effects of MDI-2517.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Capable to understand the study procedures and providing signed informed consent as described Section 8.2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Healthy male and female participants 18 to 55 years of age inclusive, at the time of signing the informed consent. 3. Body weight of a minimum 50 kg for men and 45 kg for women and body mass index (BMI) within the range of 18.5 to 32 kg/m2 4. Participants who are generally healthy as determined by medical evaluation, including medical…
Interventions
- DrugMDI-2517 800mg
800mg MDI-2517 will be administered
- OtherPlacebo
Matching Placebo
- DrugMDI-2517 1600mg
MDI-2517 1600mg will be adminstered
- DrugMDI-2517 2400mg
MDI-2517 2400mg will be administered
- DrugMDI-2517 3600mg
MDI-2517 3600mg will be administered
Location
- 1951 NW 7th Avenue, Suite 180Miami, Florida