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

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.