Actively Recruiting
Study of Midomafetamine in Healthy Adults
Led by Resilient Pharmaceuticals · Updated on 2026-05-13
32
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
Sponsors
R
Resilient Pharmaceuticals
Lead Sponsor
D
Dr. Vince Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This Phase 1 study is designed to evaluate the safety and tolerability of midomafetamine in healthy adult participants. The study will also assess how the drug is processed in the body and characterize its effects following administration at two dose levels, including evaluation of cardiac safety using electrocardiographic assessments. This is a single-center, open-label study in which participants will be enrolled into one of two cohorts receiving either a therapeutic dose or a supratherapeutic dose of midomafetamine. Participants will receive study drug in a split dose administration (an initial dose followed by an additional dose 1.5 hours later) and will undergo clinical assessments, laboratory testing, electrocardiographic monitoring, and monitoring for adverse events. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.
CONDITIONS
Official Title
Study of Midomafetamine in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 55 years
- Medically healthy based on medical history, physical exam, lab tests, vital signs, and electrocardiogram
- Able and willing to follow study procedures
You will not qualify if you...
- History of significant cardiovascular, neurological, or psychiatric disease
- Current or recent substance use disorder or positive drug/alcohol screen at screening
- Prior exposure to midomafetamine exceeding allowed limits (no more than 10% of participants)
- Any condition making participation unsafe or affecting study results, as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212
Actively Recruiting
Research Team
R
Resilient Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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