RE104 Clinical Lactation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2025-06-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Lactation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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30 mg RE104

A single subcutaneous injection of 30 mg RE104 for Injection

Group Type EXPERIMENTAL

RE104 for Injection

Intervention Type DRUG

Single, subcutaneous dose of RE104 for Injection

Interventions

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RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes