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

NCT06453824 | Completed Phase 1 FDA Drug

• 1 other identifier: MDI-2517-01-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety and Tolerability

Outcome Measures

Primary Outcomes (1)

• To evaluate the incidence of treatment emergent adverse events [safety and tolerability] of a single-ascending oral dose of MDI-2517 in healthy participants

  Adverse reactions to the study drug MDI-2517 will be measured

  5 days

Secondary Outcomes (1)

• To evaluate the levels of MDI-2517 in blood plasma following a single oral dose of MDI-2517 in healthy participants

  5 days

Study Arms (8)

Single Ascending Dose (SAD) 1

ACTIVE COMPARATOR

MDI-2517 tablet, single oral dose or placebo

Drug: MDI-2517; Other: Placebo

SAD 2

ACTIVE COMPARATOR

less than or equal to twice the highest MDI2517 dose administered to date, or placebo

Drug: MDI-2517; Other: Placebo

SAD 3

ACTIVE COMPARATOR

less than or equal to twice the highest MDI2517 dose administered to date, or placebo

Drug: MDI-2517; Other: Placebo

SAD 4

ACTIVE COMPARATOR

less than or equal to twice the highest MDI2517 dose administered to date, or placebo

Drug: MDI-2517; Other: Placebo

SAD 5

ACTIVE COMPARATOR

less than or equal to twice the highest MDI2517 dose administered to date, or placebo

Drug: MDI-2517; Other: Placebo

SAD 6

ACTIVE COMPARATOR

less than or equal to twice the highest MDI2517 dose administered to date, or placebo

Drug: MDI-2517; Other: Placebo

SAD 7

ACTIVE COMPARATOR

less than or equal to twice the highest MDI2517 dose administered to date, or placebo

Drug: MDI-2517; Other: Placebo

SAD 8

ACTIVE COMPARATOR

less than or equal to twice the highest MDI2517 dose administered to date, or placebo

Drug: MDI-2517; Other: Placebo

Interventions

MDI-2517 DRUG

study drug

SAD 2; SAD 3; SAD 4; SAD 5; SAD 6; SAD 7; SAD 8; Single Ascending Dose (SAD) 1

Placebo OTHER

matching placebo

SAD 2; SAD 3; SAD 4; SAD 5; SAD 6; SAD 7; SAD 8; Single Ascending Dose (SAD) 1

Eligibility Criteria

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

You may qualify if:

• Able to understand the study procedures and provide signed informed consent, which includes following the requirements in the informed consent form (ICF) and protocol.
• 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.
• 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 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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
• Any acute infections within 14 days of screening.
• Vaccination received within 1 month of screening.
• Participants known or suspected of not being able to comply with this study (eg, due to alcoholism, drug dependency or psychological disorder).
• Any clinically significant lab abnormalities
• Abnormal ECG findings
• Abnormal screening estimated glomerular filtration rate
• Positive test results for Hepatitis B, hepatitis C virus antibody, or human immunodeficiency virus (HIV). Negative evaluation for coronavirus disease 2019 (COVID-19).
• History of significant allergic reactions to any drug.
• 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
• Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs, eg, acetylsalicylic acid) or selective serotonin reuptake inhibitors within 7 days prior to screening.
• 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.
• 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

Sponsors & Collaborators

• MDI Therapeutics, Inc.: lead

Study Sites (1)

1951 NW 7th Avenue, Suite 180

Miami, Florida, 33136, United States

Location

Study Officials

• David Wyatt, MD

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a placebo controlled double blind study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 sentinel patients will be treated with one dose of MDI-2517 or placebo and if safe after 48h, 6 additional patients will be dosed (5 on MDI-2517 and 1 on placebo). Progression to enroll the next new group of patients will happen after review of safety and available PK data by the Safety Review Committee (SRC). The SRC will decide to move to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional doses. Patients are randomized to MDI-2517 or Placebo.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 12, 2024
• Study Start: May 17, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)