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

March 11, 2025 updated by: MDI Therapeutics, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • 1951 NW 7th Avenue, Suite 180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Able to understand the study procedures and provide signed informed consent, which includes following the requirements in the informed consent form (ICF) and protocol.
  2. Healthy male and female participants from 18 to 55 years, 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 30 kg/m2.
  4. Participants who are generally healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
  5. Contraceptive use by men or women consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants should be postmenopausal, surgically sterilized, or if of childbearing potential they must agree to use effective contraception throughout the study. Women of childbearing potential and those with less than 24 weeks from menopause must undergo a urine pregnancy test at screening and the result must be negative.
  6. Participants must not eat Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices from 7 days before participants check into the clinical site until collection of the final sample.
  7. Participants must not eat or drink caffeine- or xanthine-containing products (eg, coffee, black/green tea, cola drinks, and chocolate) or energy drinks for 48 hours before participants check into the clinical site until after collection of the final PK and/or PD sample.
  8. Participants must nor drink alcohol for 24 hours before admission to the clinical site until after collection of the final PK and/or PD sample.

Exclusion Criteria:

  1. Major medical illness or unstable medical condition within 6 months of screening that affect the participant's ability to complete the study procedures follow restrictions, or affect the ability to interpret safety data that would prevent completion of study procedures or assessments.
  2. Any clinically significant abnormal finding at physical examination. Absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
  3. Chronic or ongoing active infectious disease requiring systemic treatment
  4. Any acute infections within 14 days of screening.
  5. Vaccination received within 1 month of screening.
  6. Participants known or suspected of not being able to comply with this study (eg, due to alcoholism, drug dependency or psychological disorder).
  7. Any clinically significant lab abnormalities
  8. Abnormal ECG findings
  9. Abnormal screening estimated glomerular filtration rate
  10. Positive test results for Hepatitis B, hepatitis C virus antibody, or human immunodeficiency virus (HIV). Negative evaluation for coronavirus disease 2019 (COVID-19).
  11. History of significant allergic reactions to any drug.
  12. Use of prescription or nonprescription drugs, including vitamins, herbal and dietary supplements within 7 days or 5 half-lives prior to the first dose of study drug
  13. Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs, eg, acetylsalicylic acid) or selective serotonin reuptake inhibitors within 7 days prior to screening.
  14. Positive urine cotinine test. Use of tobacco products or uses other nicotine-containing products from screening until final follow-up visit. Use of cigarettes 3 months before screening until final visit.
  15. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week
  16. History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Single Ascending Dose (SAD) 1
MDI-2517 tablet, single oral dose or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug
Active Comparator: SAD 2
less than or equal to twice the highest MDI2517 dose administered to date, or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug
Active Comparator: SAD 3
less than or equal to twice the highest MDI2517 dose administered to date, or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug
Active Comparator: SAD 4
less than or equal to twice the highest MDI2517 dose administered to date, or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug
Active Comparator: SAD 5
less than or equal to twice the highest MDI2517 dose administered to date, or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug
Active Comparator: SAD 6
less than or equal to twice the highest MDI2517 dose administered to date, or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug
Active Comparator: SAD 7
less than or equal to twice the highest MDI2517 dose administered to date, or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug
Active Comparator: SAD 8
less than or equal to twice the highest MDI2517 dose administered to date, or placebo
Other: Placebo
matching placebo
Drug: MDI-2517
study drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the incidence of treatment emergent adverse events [safety and tolerability] of a single-ascending oral dose of MDI-2517 in healthy participants
Time Frame: 5 days
Adverse reactions to the study drug MDI-2517 will be measured
5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the levels of MDI-2517 in blood plasma following a single oral dose of MDI-2517 in healthy participants
Time Frame: 5 days
The levels of MDI-2517 in blood plasma following an oral single-dose of MDI-2517 tablets will be measured.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MDI Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Wyatt, MD, Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDI-2517-01-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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