Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07584720

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

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Dr. Vince Clinical Research

Overland Park, Kansas, United States, 66212

Actively Recruiting

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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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