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

MDI Therapeutics, Inc.1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年5月17日最近更新: 2025年3月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: MDI Therapeutics, Inc.
入组人数: 48
试验地点: 1
主要终点: To evaluate the incidence of treatment emergent adverse events [safety and tolerability] of a single-ascending oral dose of MDI-2517 in healthy participants

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

盲法说明

This is a placebo controlled double blind study

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Able to understand the study procedures and provide signed informed consent, which includes following the requirements in the informed consent form (ICF) and protocol.
•Healthy male and female participants from 18 to 55 years, 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 30 kg/m
•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 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.
•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.
•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.
•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.

排除标准

•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.
•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.
•Chronic or ongoing active infectious disease requiring systemic treatment
•Any acute infections within 14 days of screening.
•Vaccination received within 1 month of screening.
•Participants known or suspected of not being able to comply with this study (eg, due to alcoholism, drug dependency or psychological disorder).
•Any clinically significant lab abnormalities
•Abnormal ECG findings
•Abnormal screening estimated glomerular filtration rate
•Positive test results for Hepatitis B, hepatitis C virus antibody, or human immunodeficiency virus (HIV). Negative evaluation for coronavirus disease 2019 (COVID-19).
•History of significant allergic reactions to any drug.
•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
•Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs, eg, acetylsalicylic acid) or selective serotonin reuptake inhibitors within 7 days prior to screening.
•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.
•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
•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.

研究组 & 干预措施

Single Ascending Dose (SAD) 1

Active Comparator

MDI-2517 tablet, single oral dose or placebo

干预措施: MDI-2517 (Drug)

Single Ascending Dose (SAD) 1

Active Comparator

MDI-2517 tablet, single oral dose or placebo

干预措施: Placebo (Other)