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First received: October 14, 2024

Clinical Trial: RE104 Clinical Lactation Study

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Lactation

Study Type: INTERVENTIONAL


Official Title: A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.

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.

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