MDI-2517 for Safety

Overseen By Jessica Reed, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: MDI Therapeutics, Inc.

Must not be taking: NSAIDs, SSRIs, MAOIs, others

Disqualifiers: Major illness, Infections, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day for SAD cohorts, 7 days for MAD cohorts

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new drug, MDI-2517, in healthy participants. Researchers aim to understand how the body processes the drug and whether it causes any side effects. Participants will receive either the actual drug or a placebo (a treatment with no active ingredient) in varying doses. This trial suits generally healthy individuals who can easily avoid certain foods and drinks, such as grapefruit and caffeine. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking most medications, including prescription and nonprescription drugs, vitamins, and supplements, at least 7 days before the trial starts. However, oral contraception and occasional use of acetaminophen are exceptions.

Is there any evidence suggesting that MDI-2517 is likely to be safe for humans?

Research has shown that MDI-2517 is under study to determine its safety for people. As the drug is in the early testing stages, detailed safety information remains limited. However, testing on healthy volunteers suggests researchers consider it potentially safe for human trials.

In these early trials, participants receive varying doses to identify any side effects. Although specific side effects are not listed, the continuation of these tests suggests no major safety concerns have arisen. These studies are crucial for finding the safest dose levels and identifying potential risks before the drug can be used more widely. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MDI-2517 is unique because it targets a different mechanism compared to existing treatments for its condition. Most current therapies focus on symptom management or general inflammation pathways, but MDI-2517 is designed to target specific cellular processes, potentially offering a more precise treatment. Additionally, its flexible dosing options—from once daily to twice daily, and adjustable dosages reaching up to 3600 mg—allow for tailored treatment plans, which could lead to better patient outcomes. Researchers are excited because this adaptability might lead to more effective management of the condition with fewer side effects.

What evidence suggests that this trial's treatments could be effective?

Research shows that MDI-2517 is being tested primarily for safety and efficacy in healthy individuals. Although detailed information on its effectiveness in humans is limited, researchers are considering the drug as a potential treatment for diseases like systemic sclerosis (SSc) and interstitial lung disease (ILD). MDI-2517 may work by influencing certain processes involved in these diseases. The current trial includes different arms where participants receive varying doses of MDI-2517 or a matching placebo to understand the drug's interaction with the body and identify any possible side effects. Further studies are necessary to confirm its effectiveness in treating these specific diseases. ^{1 2 3 4 5}

Who Is on the Research Team?

David Wyatt, MD

Principal Investigator

MDI Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to help test the safety of a new drug, MDI-2517. Specific details about age, health conditions, or other criteria aren't provided here but are important for determining eligibility.

Inclusion Criteria

Ability to refrain from consumption of 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 PK sample for each participant.

I am between 18 and 55 years old and healthy.

I understand the study's procedures and have signed the informed consent.

Exclusion Criteria

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.

Participants known or suspected of not being able to comply with this study protocol (eg, due to alcoholism, drug dependency or psychological disorder)

Laboratory values as follows: Any clinically significant lab abnormalities, AST or ALT; > the upper limit of normal (ULN), Total bilirubin > 1.5 times ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%), Platelet counts < 150 × 10^9/L or > 450 × 10^9/L, Hemoglobin outside of normal limits, Coagulation tests (prothrombin time, partial thromboplastin time) outside of normal limits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

28 days

Treatment

Participants receive single or multiple ascending doses of MDI-2517 or placebo

1 day for SAD cohorts, 7 days for MAD cohorts

Monitoring

Participants are monitored for safety, pharmacokinetics, and pharmacodynamics after dosing

6 days for SAD cohorts, 12 days for MAD cohorts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MDI-2517
• Placebo

Trial Overview The study tests different doses of MDI-2517 (800mg to 3600mg) compared with a placebo. Participants will take either single or multiple doses and researchers will monitor safety and how the body processes the drug.

How Is the Trial Designed?

Group I: MAD 1 Active Control 2 Interventions

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 II: MAD 2 Active Control 2 Interventions

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 III: MAD 3 Active Control 2 Interventions

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.

Group IV: SAD 1 Active Control 2 Interventions

SAD cohort 1 will receive a single oral dose of 2400 mg of MDI-2517 or matching placebo

Group V: SAD 2 Active Control 2 Interventions

SAD cohort 2 will receive a single oral dose up to 3600 mg of MDI-2517 or matching placebo.

Who Is Running the Clinical Trial?

MDI Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06453824

SAD Evaluation of Safety, Tolerability, PK, and PD of MDI- ... 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 ...

2. withpower.com withpower.com/trial/phase-1-safety-and-tolerability-4-2024-08d8e

MDI-2517 for Safety and Tolerability · Info for Participants The provided research does not contain specific safety data for MDI-2517. However, it references databases like DART and DIMDI that contain information on ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/mdi-therapeutics-phase-i-ssc-ild-study/

MDI Therapeutics: Enrol 48 Participants in Phase I Study MDI Therapeutics has dosed the first participants in a Phase I study to support the development of a potential treatment for SSc and ILD.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06453824/sad-evaluation-of-safety-tolerability-pk-and-pd-of-mdi-2517-in-healthy-participants

SAD Evaluation of Safety, Tolerability, PK, and PD of MDI- ... This is a Phase 1 study to test the safety and drug effects of MDI-2517 when given once in healthy volunteers.

5. patlynk.com patlynk.com/trial/NCT07220889

MDI-2517 Safety and Effects in Healthy Volunteers 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.