drugset / Trial / NCT06659263
RE104 Clinical Lactation Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RE104 | Unknown | 30 mg | Subcutaneous |