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

Inclusion Criteria:

1. Able to understand the study procedures and provide signed informed consent, whichincludes 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 theinformed 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 cardiacmonitoring.

5. Contraceptive use by men or women consistent with local regulations regarding themethods of contraception for those participating in clinical studies. Femaleparticipants should be postmenopausal, surgically sterilized, or if of childbearingpotential they must agree to use effective contraception throughout the study. Womenof childbearing potential and those with less than 24 weeks from menopause mustundergo 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 beforeparticipants 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 hoursbefore participants check into the clinical site until after collection of the finalPK and/or PD sample.

8. Participants must nor drink alcohol for 24 hours before admission to the clinicalsite 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 screeningthat affect the participant's ability to complete the study procedures followrestrictions, or affect the ability to interpret safety data that would preventcompletion of study procedures or assessments.

2. Any clinically significant abnormal finding at physical examination. Absence ofclinically 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, dueto 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 humanimmunodeficiency 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 dietarysupplements within 7 days or 5 half-lives prior to the first dose of study drug

13. Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs, eg, acetylsalicylicacid) or selective serotonin reuptake inhibitors within 7 days prior to screening.

14. Positive urine cotinine test. Use of tobacco products or uses othernicotine-containing products from screening until final follow-up visit. Use ofcigarettes 3 months before screening until final visit.

15. History of alcohol abuse within 1 year prior to screening or regular use of alcoholwithin 6 months prior to screening that exceeds 7 units for women or 14 units formen of alcohol per week

16. History of drug abuse within 1 year prior to screening or recreational use of softdrugs within 1 month or hard drugs within 3 months prior to screening.