Trials / Completed
CompletedNCT06659263
RE104 Clinical Lactation Study
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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Reunion Neuroscience Inc · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RE104 for Injection | Single, subcutaneous dose of RE104 for Injection |
Timeline
- Start date
- 2024-11-13
- Primary completion
- 2025-05-28
- Completion
- 2025-06-04
- First posted
- 2024-10-26
- Last updated
- 2025-06-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06659263. Inclusion in this directory is not an endorsement.