MedTrace Logo

RE104 Clinical Lactation Study

NCT06659263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-06-12

No results posted yet for this study

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

Interventions

DRUG

RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Sponsors & Collaborators

  • Reunion Neuroscience Inc

    lead INDUSTRY

Principal Investigators

  • Mark Pollack, Chief Medical Officer · Reunion Neurosciences Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2025-05-28
Completion
2025-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659263 on ClinicalTrials.gov