drugset / Trial / NCT06659263

RE104 Clinical Lactation Study

NCT06659263 ↗

Phase 1 Completed 14 enrolled Reunion Neuroscience Inc
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-11-13
Primary completion
2025-05-28
Completion
2025-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject RE104 Unknown 30 mg Subcutaneous

Indications