CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 342 enrolled
Drug / intervention
MEDI8897 Intravenous +5 moredrug
Likely dose
MEDI8897 Intravenous 300 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/NCT02114268
NCT02114268Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

MedImmune LLC·interventional·Posted Apr 15, 2014·Updated Nov 28, 2016

In Brief

A Phase 1 clinical trial evaluating MEDI8897 Intravenous, Placebo, and 1 other intervention for Respiratory Syncytial Virus Infections. Completed, enrolled 342 participants across 1 site.

Detailed Summary

The purpose of this study was 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 adult participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 15, 2014
Enrollment StartApr 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.2 years ago

Interventions

MEDI8897 Intravenousdrug

Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.

Placebodrug

Participants received placebo on Day 1.

MEDI8897 Intravenousdrug

Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.

MEDI8897 Intravenousdrug

Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.

MEDI8897 Intramusculardrug

Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.

MEDI8897 Intramusculardrug

Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.