NCT07220889

Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: MDI Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Safety After Oral Intake

Interventions

Type	Name	Description
DRUG	MDI-2517 800mg	800mg MDI-2517 will be administered
OTHER	Placebo	Matching Placebo
DRUG	MDI-2517 1600mg	MDI-2517 1600mg will be adminstered
DRUG	MDI-2517 2400mg	MDI-2517 2400mg will be administered
DRUG	MDI-2517 3600mg	MDI-2517 3600mg will be administered

Timeline

• Start date: 2025-11-04
• Primary completion: 2026-05-04
• Completion: 2026-06-04
• First posted: 2025-10-24
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study