Actively Recruiting
Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
Led by MDI Therapeutics, Inc. · Updated on 2025-10-24
52
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide signed informed consent
- Healthy males and females aged 18 to 55 years inclusive
- Body weight at least 50 kg for men and 45 kg for women, with BMI between 18.5 and 32 kg/m2
- Generally healthy based on medical evaluation including history, physical exam, labs, and cardiac monitoring
- Women must be postmenopausal, surgically sterilized, or use highly effective contraception if of childbearing potential
- Able to avoid certain citrus fruits and juices from 7 days before admission until final sample collection
- Able to abstain from caffeine or xanthine products for 48 hours before admission until after final sample collection
- Able to abstain from alcohol for 24 hours before admission until after final sample collection
- Able to swallow multiple tablets within 10 minutes
You will not qualify if you...
- Major or unstable medical illness within 6 months before screening
- Clinically significant abnormalities in physical exam or history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic diseases
- Chronic or active infections requiring systemic treatment
- Acute infections within 14 days of screening
- Recent live attenuated vaccines within 1 month or other vaccines within 14 days before screening
- Unable to comply with study due to alcoholism, drug dependency, or psychological disorder
- Significant lab abnormalities including elevated liver enzymes, abnormal bilirubin, abnormal platelet counts, hemoglobin, or coagulation tests
- Prolonged QT interval on ECG
- Reduced kidney function (eGFR <90 mL/min/1.73m2)
- Positive tests for Hepatitis B, C, HIV, or COVID-19 infection
- History of severe allergic reactions to drugs
- Use of most medications, supplements, or certain drugs within specified timeframes before dosing
- Recent use of NSAIDs or SSRIs within 7 days before screening
- Use of tobacco or nicotine-containing products within 3 months before screening
- History of alcohol abuse or excessive alcohol use
- History of drug abuse or recent recreational drug use
- Allergies to platelet products or plasma proteins
- Known platelet function disorders or increased risk of blood clots
- Recent blood donations or significant blood loss
- Participation in another clinical trial or prior exposure to MDI-2517
- Positive pregnancy test or currently breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
1951 NW 7th Avenue, Suite 180
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Jessica Reed, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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