RE104 Clinical Lactation Study

Reunion Neuroscience

Status and phase: Completed; Phase 1

Conditions: Lactation

Treatments: Drug: RE104 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06659263

RE104-102-NHLV

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

30 mg RE104

Experimental group

Description:

A single subcutaneous injection of 30 mg RE104 for Injection

Treatment:

Drug: RE104 for Injection