MedTrace Logo

Single and Multiple Intravenous Administrations of Estetrol (E4) in Healthy Adult Volunteers

NCT05460065 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-07-04

No results posted yet for this study

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.

Conditions

  • Safety
  • Pharmacokinetics

Interventions

DRUG

single E4 28.3 mg

Administration of a single intravenous (i.v.) infusion of estetrol (E4) 28.3 mg (n=6)

DRUG

single E4 94.4 mg

Administration of a single i.v. infusion of E4 94.4 mg (n=6)

DRUG

multiple E4 94.4 mg

Administration of an i.v. infusion of E4 94.4 mg (or lower dose, depending on single dose results) once a day for 5 consecutive days (n=8)

DRUG

Placebo

Cohort A: Single dose of placebo (n=2); Cohort B: Single dose of placebo (n=2); Cohort C: multiple dose of placebo (n=4)

Sponsors & Collaborators

  • NEURALIS s.a.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2022-09-13
Completion
2022-09-13

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05460065 on ClinicalTrials.gov