Pharmacokinetics Clinical Trial
Official title:
A Double-blind, Placebo-controlled Phase I Study to Characterize the Safety, Tolerability and Pharmacokinetics (PK) of Estetrol (E4) After Single and Multiple Intravenous Administrations in Healthy Adult Volunteers
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.
The study will be conducted in a dose escalation design, starting with a single dose of 30 mg (Cohort A). After completion of the treatment period of the cohort, a review of the safety and tolerability data will be performed by a blinded dose-escalation safety review team (DESRT) consisting of medical and research experts of the Sponsor and CRO, and the principal investigator. If this review is satisfactory, the study will be continued with a next cohort of volunteers who will receive a higher single dose of 100 mg (Cohort B). A safety review will be applied again for moving from the single dose Cohort B to the multiple dose cohort (Cohort C). At this stage, the safety review team may decide to reduce the daily dose to be used for the multiple dose cohort from what is initially proposed in the protocol. ;
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