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

Safety and Tolerability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453824
• Other study ID #: MDI-2517-01-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 17, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: MDI Therapeutics, Inc.
• Contact: Jessica Reed, PhD
• Phone: 7344786625
• Email: jreed[@]mditherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety and Tolerability

Intervention

Drug:
• MDI-2517
study drug

Other:
• Placebo
matching placebo

Locations

Country	Name	City	State
United States	1951 NW 7th Avenue, Suite 180	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MDI Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the levels of MDI-2517 in blood plasma following a single oral dose of MDI-2517 in healthy participants	The levels of MDI-2517 in blood plasma following an oral single-dose of MDI-2517 tablets will be measured.	5 days