CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 151 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
MEDI8897 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02290340
NCT02290340Phase 1Completed
CompareCT.gov

A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

MedImmune LLC·interventional·Posted Nov 14, 2014·Updated Sep 19, 2018

In Brief

A Phase 1 clinical trial evaluating Placebo, MEDI8897 10 mg, and 2 other interventions for Respiratory Syncytial Virus. Completed, enrolled 151 participants across 13 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus
CountriesChile, South Africa, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 14, 2014
Enrollment StartJan 13, 2015
Primary CompletionSep 28, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.6 years ago

Interventions

Placebodrug

Participants will receive placebo intramuscularly.

MEDI8897 10 mgdrug

Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.

MEDI8897 25 mgdrug

Participants will receive a single dose of MEDI8897 25 mg intramuscularly.

MEDI8897 50 mgdrug

Participants will receive a single dose of MEDI8897 50 mg intramuscularly.