RE104 Clinical Lactation Study

A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.

The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.

Study Overview

• Status: Completed
• Conditions: Lactation
• Intervention / Treatment: Drug: RE104 for Injection

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • PPD Inc

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Females between 18 and 45 years of age, at least 50 kgs, and a body mass index of 18-34 kg/m2
• Has been breastfeeding or actively pumping for at least 4 weeks postpartum
• Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening.
• Willing and able to pump in order to maintain sufficient milk supply volumes for the study
• Is not pregnant or planning to become pregnant during the study
• Able to understand and adhere to study schedule and requirements and willing to sign an ICF
• In good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening

Exclusion Criteria:

• Has mastitis or other condition that would prevent the collection of milk from one or both breasts
• Active or medical history of significant mental disorder (including but not necessarily limited to major depression and anxiety disorders, bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder), or first-degree family history of psychosis or bipolar disorder
• Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator
• Has used or intends to use of prohibited medications
• Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 mg RE104; A single subcutaneous injection of 30 mg RE104 for Injection	Drug: RE104 for Injection; Single, subcutaneous dose of RE104 for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for RE104 and 4-OH-DiPT in plasma and breast milk	Through 24 hours postdose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for RE104 and 4-OH-DiPT in plasma and breast milk	Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk	Through 168 hours postdose
Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk	Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma	Through 168 hours postdose
Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk	Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104 in plasma	Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma	Through 168 hours postdose
Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT	Through 72 hours postdose
Total RID of RE104 and its active entity 4-OH-DiPT	Through 168 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.	A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.	From dosing through study completion (post-dose follow-up is for 14 days)
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for detectable/quantifiable RE104 metabolites in plasma and breast milk		Through 24 hours postdose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for detectable/quantifiable RE104 metabolites in plasma and breast milk		Through 168 hours postdose
Maximum observed concentration (Cmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk		Through 168 hours postdose
Time to reach Cmax (tmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk		Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for detectable/quantifiable RE104 metabolites in plasma		Through 168 hours postdose
Milk to plasma (M/P) ratio for detectable/quantifiable RE104 metabolites in breast milk		Through 168 hours postdose
Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT.		1, 3 and 8 hours post-dose
Amount of RE104 and its active entity 4 OH-DiPT excreted into breast milk (Ae) and amount of drug excreted into breast milk relative to dose (Fe)		Through 168 hours postdose

Collaborators and Investigators

• Sponsor: Reunion Neuroscience Inc
• Investigators: Study Director: Mark Pollack, Chief Medical Officer, Reunion Neurosciences Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RE104-102-NHLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No