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MDI-2517 Safety and Effects in Healthy Volunteers

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Study AimThis study aims to evaluate the safety and effects of MDI-2517 in healthy volunteers.
What is being tested

MDI-2517 800mg

+ Placebo
+ MDI-2517 1600mg
Drug
Other
Who is being recruted

Safety After Oral Intake

From 18 to 55 Years
+37 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorMDI Therapeutics, Inc.
Study ContactJessica Reed, PhD
Last updated: October 24, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 4, 2025Actual date on which the first participant was enrolled.

This clinical trial aims to determine if the drug MDI-2517 is safe for use and to understand how it affects the body in healthy individuals. The study targets healthy participants to ensure that any observations are strictly due to the drug, rather than underlying health conditions. By identifying any potential side effects and understanding how the drug behaves in the body, this research could pave the way for future treatments involving MDI-2517, possibly aiding in the development of new medications. Participants in this study will receive either single or multiple doses of MDI-2517. The trial involves close monitoring of participants for any adverse events, changes in vital signs, and alterations in laboratory test outcomes. Additionally, electrocardiograms and drug levels in the blood and urine will be analyzed. This comprehensive monitoring helps researchers gather detailed information about the drug's safety and how it is processed by the body, contributing to the overall understanding of its effects.

Official TitleA 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 
Principal SponsorMDI Therapeutics, Inc.
Study ContactJessica Reed, PhD
Last updated: October 24, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
52 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Safety After Oral Intake
Criteria
9 inclusion criteria required to participate
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
Healthy male and female participants 18 to 55 years of age inclusive, at the time of signing the informed consent
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
Participants who are generally healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring

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28 exclusion criteria prevent from participating
Major medical illness or unstable medical condition within 6 months of screening that in the opinion of the investigator may interfere with the participant's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data that would prevent completion of study procedures or assessments
Any clinically significant abnormal finding at Screening during the physical examination or a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
Chronic or ongoing active infectious disease requiring systemic treatment including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, and tuberculosis
Any acute infections within 14 days of screening

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
5 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
SAD cohort 1 will receive a single oral dose of 2400 mg of MDI-2517 or matching placebo
Group II
Active Comparator
SAD cohort 2 will receive a single oral dose up to 3600 mg of MDI-2517 or matching placebo.
Group III
Active Comparator
MAD cohort 1 will receive a total daily dose of 800 mg of MDI-2517 or matching placebo administered either once daily (QD) or twice daily (BID).
Group IV
Active Comparator
MAD cohort 2 will receive a total daily dose of up to 1600 mg of MDI-2517 or matching placebo administered either QD or BID.
Group 5
Active Comparator
MAD cohort 3 will receive a total daily dose of up to 2400 mg of MDI-2517 or matching placebo administered either QD or BID.
Study Objectives
Primary Objectives

Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants. This outcome will be measured using: the number of participants with adverse events (AEs), with abnormal laboratory tests results (chemistry, hematology, coagulation), abnormal vital signs and changes in electrocardiogram" * The type, incidence, severity, seriousness, and relatedness of adverse events (AEs) * The type, incidence, and severity of laboratory abnormalities and changes (chemistry, hematology, coagulation) * Changes in vital signs, and changes in electrocardiogram (ECG QT prolongation) at specified timepoints
Secondary Objectives

Evaluate the plasma pharmacokinetic (PK) profile of MDI-2517 following ascending single oral doses of MDI2517 in healthy participants. This outcome - the PK profile of MDI-2517- will be measured by analyzing blood samples measuring: Cmax; tmax; AUC0-24; AUC0-t; AUC0-inf; t½; λz; CL/F; Vz/F; and linearity factor)

Evaluate the plasma PK profile of MDI-2517 following ascending multiple oral doses of MDI-2517 in healthy participants. This outcome - the PK profile of MDI-2517- will be measured by analyzing blood samples- and will be measured using: Cmax; Cmin; tmax; AUC0-24; AUC0-t; AUC0-inf (Day 1 only); t½; λz; CL/F; Vz/F; linearity factor; and accumulation index ratios for Cmax and AUCs.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
1951 NW 7th Avenue, Suite 180Miami, United StatesSee the location
Recruiting
One Study Center