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

NCT07220889 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MDI-2517-01-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

single ascending dose; multiple ascending dose; safety; pharmacokinetics; pharmacodynamics; MDI-2517

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants

  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

  SAD cohorts are up to 34 days - up to 28 days for screening, 1 day of dosing (for SAD cohorts) and 6 days of monitoring. MAD cohorts are up to 40 days - up to 28 days for screening. 7 days of dosing (for MAD cohorts) 12 days of monitoring.

Secondary Outcomes (2)

• Evaluate the plasma pharmacokinetic (PK) profile of MDI-2517 following ascending single oral doses of MDI2517 in healthy participants

  SAD cohorts are up to 34 days- Screening up to 28 days. 1 day of dosing (for SAD cohorts) and 6 days of monitoring.

• Evaluate the plasma PK profile of MDI-2517 following ascending multiple oral doses of MDI-2517 in healthy participants

  MAD cohorts are up to 40 days. Screening up to 28 days. dosing on days 1 to 7 (for MAD cohorts) and 12 days of monitoring.

Other Outcomes (2)

• Determine the renal excretion of MDI-2517 and analysis of MDI-2517 and metabolites following multiple oral doses.

  MAD cohorts are up to 40 days. Screening up to 28 days, dosing days 1-7 (for MAD cohorts) and 12 days of monitoring.

• Evaluate target engagement and pharmacodynamic (PD) effects of MDI-2517 following multiple oral doses

  MAD cohorts are up to 40 days. Screening up to 28 days. Dosing days 1 to 7 (for MAD cohorts) and 12 days of monitoring.

Study Arms (5)

SAD 1

ACTIVE COMPARATOR

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

Other: Placebo; Drug: MDI-2517 2400mg

SAD 2

ACTIVE COMPARATOR

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

Other: Placebo; Drug: MDI-2517 3600mg

MAD 1

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).

Drug: MDI-2517 800mg; Other: Placebo

MAD 2

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.

Other: Placebo; Drug: MDI-2517 1600mg

MAD 3

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.

Other: Placebo; Drug: MDI-2517 2400mg

Interventions

MDI-2517 800mg DRUG

800mg MDI-2517 will be administered

MAD 1

Placebo OTHER

Matching Placebo

MAD 1; MAD 2; MAD 3; SAD 1; SAD 2

MDI-2517 1600mg DRUG

MDI-2517 1600mg will be adminstered

MAD 2

MDI-2517 2400mg DRUG

MDI-2517 2400mg will be administered

MAD 3; SAD 1

MDI-2517 3600mg DRUG

MDI-2517 3600mg will be administered

SAD 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants should be of nonchildbearing potential (postmenopausal i.e., spontaneous amenorrhea for at least 12 months prior to dosing with confirmatory follicle-stimulating hormone \[FSH\] \> 40 mIU/mL, or premenopausal and surgically sterilized), or of childbearing potential who agree to take highly effective contraceptive measures throughout the trial (see Section 11.15 for highly effective contraceptive guidance). Sexually active female participants of childbearing potential with non-sterile male partners, and sexually active non-surgically sterile male participants with female partners of childbearing potential will be required to use highly effective double contraceptive method. Women of childbearing potential and those with less than 24 weeks from menopause must undergo a urine pregnancy test at screening and result must be negative.
• 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.
• Ability to abstain from ingesting 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.
• Ability to abstain from alcohol for 24 hours before admission to the clinical site until after collection of the final PK and/or PD sample.
• Ability to swallow multiple tablets within a 10 minute window.

You may not qualify if:

• 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.
• Live attenuated vaccines received within 1 month of screening. Other vaccines, including coronavirus 2019 (COVID-19) vaccine, within 14 days prior to Screening.
• 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 × 109/L or \> 450 × 109/L
• Hemoglobin outside of normal limits
• Coagulation tests (prothrombin time, partial thromboplastin time) outside of normal limits
• Screening corrected QT interval (QTc) \> 450 milliseconds for males and \> 470 ms for females. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine read or manually overread.
• Screening estimated glomerular filtration rate (eGFR) using 2021 CKD-EPI method \<90 mL/min/1.73m2

Sponsors & Collaborators

• MDI Therapeutics, Inc.: lead

Study Sites (1)

1951 NW 7th Avenue, Suite 180

Miami, Florida, 33136, United States

RECRUITING

Study Officials

• David Wyatt, MD

  MDI Therapeutics, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Reed, PhD

CONTACT

17344786625; jreed@mditherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2025
• First Posted: October 24, 2025
• Study Start: November 4, 2025
• Primary Completion: May 4, 2026
• Study Completion (Estimated): June 4, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)