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

NCT07220889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Safety After Oral Intake

Interventions

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

Sponsors & Collaborators

  • MDI Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Wyatt, MD · MDI Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2025-12-16
Completion
2026-01-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220889 on ClinicalTrials.gov