NCT06453824

SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: MDI Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 study to test the safety and drug effects of MDI-2517 when given once in healthy volunteers.

Detailed description

This is a first-in-human study in healthy adult volunteers to assess the safety, tolerability, and pharmacokinetics (PK), with additional exploratory objective to assess pharmacodynamics (PD) of a single dose of MDI-2517.

Conditions

• Safety and Tolerability

Interventions

Type	Name	Description
DRUG	MDI-2517	study drug
OTHER	Placebo	matching placebo

Timeline

• Start date: 2024-05-17
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2024-06-12
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study