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Monoclonal Antibodies

MDI-2517 for Safety and Tolerability

Phase 1
Recruiting
Led By David Wyatt, MD
Research Sponsored by MDI Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male and female participants from 18 to 55 years, 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 30 kg/m2
Must not have
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
Chronic or ongoing active infectious disease requiring systemic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Summary

"This trial is testing the safety and effects of a drug called MDI-2517 in healthy volunteers by giving it to them once."

Who is the study for?
This trial is for healthy individuals who meet specific health standards. The exact inclusion and exclusion criteria are not provided, but typically participants should have no significant medical conditions, not be on conflicting medications, and must be willing to follow the study procedures.
What is being tested?
The trial is testing MDI-2517's safety and how it's processed in the body (pharmacokinetics) and its effects on the body (pharmacodynamics). It's a Phase 1 study where volunteers receive one dose of MDI-2517 to evaluate these factors.
What are the potential side effects?
Since this is an early-stage trial for MDI-2517, potential side effects are being investigated. Common side effects in such trials can include headache, nausea, fatigue or reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old and healthy.
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I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 18.5 and 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have any major health issues apart from my current condition.
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I am currently being treated for a long-term infection.
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I have no major illness or condition that would stop me from completing the study.
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I have not had any infections in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the incidence of treatment emergent adverse events [safety and tolerability] of a single-ascending oral dose of MDI-2517 in healthy participants
Secondary outcome measures
To evaluate the levels of MDI-2517 in blood plasma following a single oral dose of MDI-2517 in healthy participants

Trial Design

6Treatment groups
Active Control
Group I: Single Ascending Dose (SAD) 1Active Control2 Interventions
MDI-2517 tablet, single oral dose or placebo
Group II: SAD 2Active Control2 Interventions
less than or equal to twice the MDI2517 tablets, single oral dose from SAD1 or placebo
Group III: SAD 3Active Control2 Interventions
less than or equal to twice the MDI2517 tablets, single oral dose from SAD2 or placebo
Group IV: SAD 4Active Control2 Interventions
less than or equal to twice the MDI2517 tablets, single oral dose from SAD3 or placebo
Group V: SAD 5Active Control2 Interventions
less than or equal to twice the MDI2517 tablets, single oral dose from SAD4 or placebo
Group VI: SAD 6Active Control2 Interventions
less than or equal to twice the MDI2517 tablets, MDI2517 single oral dose from SAD5 or placebo

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MDI Therapeutics, Inc.Lead Sponsor
David Wyatt, MDPrincipal InvestigatorSyneos Health
4 Previous Clinical Trials
190 Total Patients Enrolled
~32 spots leftby Sep 2025
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