drugset / Trial / NCT05460065
Single and Multiple Intravenous Administrations of Estetrol (E4) in Healthy Adult Volunteers
RandomizedSequentialQuadruple-blindOther
Summary
The Sponsor intends to develop an intravenous (i.v.) formulation of E4 for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). E4 has not been administered intravenously to humans yet. This single-center, double-blind, placebo-controlled randomized study aims to evaluate the safety, tolerability, and PK of an i.v. E4 solution administered as single-dose or multiple dose to healthy adult volunteers.
Timeline
- Start
- 2022-04-19
- Primary completion
- 2022-09-13
- Completion
- 2022-09-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 28.3 mg | Intravenous |
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 94.4 mg | Intravenous |
Indications
No indication recorded.