Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokin… (NCT07220889) | Clinical Trial Compass
RecruitingPhase 1
Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
United States52 participantsStarted 2025-11-04
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
What they're measuring
1
Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants
Timeframe: 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.
✓. 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.
Exclusion criteria
✕. 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)