Study of Midomafetamine in Healthy Adults

A Phase 1, Single-Center, Open-Label, 2-Cohort Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Midomafetamine at Therapeutic and Supratherapeutic Doses

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Midomafetamine HCl

Detailed Description

This Phase 1 study is a dedicated safety investigation conducted in healthy adult participants to further characterize the safety and tolerability of midomafetamine under controlled dosing conditions. Participants will receive a split dose administration of midomafetamine (an initial dose of study drug followed by an additional dose 1.5 hours later) in sequential dose cohorts intended to achieve therapeutic and supratherapeutic systemic exposure.

Safety assessments include monitoring of adverse events, clinical laboratory tests, vital signs, and electrocardiographic measurements. Electrocardiographic data, including assessment of corrected QT interval, will be collected to support evaluation of cardiac safety in relation to exposure.

Because midomafetamine produces acute psychoactive effects during the dosing period, pharmacodynamic assessments-including subjective effects-will be collected to support interpretation of safety and tolerability findings. Pharmacokinetic assessments will also be performed to characterize systemic exposure.

This study is not designed to evaluate efficacy or treatment effectiveness for any disease or condition. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Resilient Pharmaceuticals; Phone Number: 877-627-7722; Email: ClinDevInquiries@resilientpharm.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Recruiting
      • Dr. Vince Clinical Research
      • Contact: Recruitment; Phone Number: 913-333-3000; Email: csounakhen@drvince.com
      • Principal Investigator: William Lavery, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adult participants, 18 to 55 years of age
• Medically healthy as determined by medical history, physical examination, clinical laboratory testing, vital signs, and electrocardiogram
• Able and willing to comply with study procedures

Exclusion Criteria:

• History of clinically significant cardiovascular, neurological, or psychiatric disease
• Current or recent substance use disorder, or positive drug or alcohol screen at screening
• Prior exposure to midomafetamine exceeding a protocol-defined limit intended to minimize confounding of safety assessments (no more than 10% of participants may have lifetime prior exposure)
• Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with interpretation of study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants receive midomafetamine administered in sequential dose cohorts. One cohort receives a targeted therapeutic dose administered in a split manner, and a subsequent cohort receives a supratherapeutic dose administered in a split manner.	Drug: Midomafetamine HCl; Midomafetamine HCl is administered orally to study participants.; Other Names: Midomafetamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Assessment of adverse events and serious adverse events following administration of midomafetamine.	From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in corrected QT interval (QTc) (ms)	Corrected QT interval (QTc) will be assessed using 12-lead ECG data and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.	Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
Maximum plasma concentration (Cmax) of midomafetamine	Plasma midomafetamine concentrations will be measured, and maximum plasma concentration (Cmax) will be derived from the concentration-time data.	Predose (Day 1) through 48 hours postdose (Day 3)
Time to maximum plasma concentration (Tmax) of midomafetamine	Plasma midomafetamine concentrations will be measured, and time to maximum plasma concentration (Tmax) will be derived from the concentration-time data.	Predose (Day 1) through 48 hours postdose (Day 3)
Area under the plasma concentration-time curve (AUC0-24) of midomafetamine	Plasma midomafetamine concentrations will be measured, and area under the concentration-time curve from time 0 to 24 hours (AUC0-24) will be derived from the concentration-time data.	Predose (Day 1) through 24 hours postdose (Day 2)
Change from baseline in subjective effects Visual Analog Scale (VAS) scores	Subjective effects will be assessed using Visual Analog Scale (VAS) instruments and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.	Baseline (predose Day 1) and up to 24 hours postdose (Day 2)

Collaborators and Investigators

• Sponsor: Resilient Pharmaceuticals
• Collaborators: Dr. Vince Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Healthy Volunteers; Pharmacodynamics; ECG; Phase 1 Study; Midomafetamine
• Additional Relevant MeSH Terms: Organic Chemicals; Amines; Phenethylamines; Ethylamines; Amphetamines; N-Methyl-3,4-methylenedioxyamphetamine
• Other Study ID Numbers: RP-CL-P1-2501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data collected in this study will not be shared. Summary level results may be reported in publications and regulatory submissions, as applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No