RE104 Clinical Lactation Study

NCT06659263 | Completed Phase 1 FDA Drug

• 1 other identifier: RE104-102-NHLV
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lactation

Outcome Measures

Primary Outcomes (10)

• 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 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

• 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

• 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 Outcomes (9)

• Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.

  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

Study Arms (1)

30 mg RE104

EXPERIMENTAL

A single subcutaneous injection of 30 mg RE104 for Injection

Drug: RE104 for Injection

Interventions

RE104 for Injection DRUG

Single, subcutaneous dose of RE104 for Injection

30 mg RE104

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reunion Neuroscience Inc: lead

Study Sites (1)

PPD Inc

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Injections

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Pollack, Chief Medical Officer

  Reunion Neurosciences Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 26, 2024
• Study Start: November 13, 2024
• Primary Completion: May 28, 2025
• Study Completion: June 4, 2025
• Last Updated: June 12, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)