CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Oseltamivir +2 moredrug
Likely dose
Oseltamivir 75 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/NCT02603952
NCT02603952Phase 2Completed
CompareCT.gov

A Phase 2a, Randomized, Partial Double-blind, Single Dose, Active-controlled, Dose Ranging Study to Evaluate the Safety of MEDI8852 in Adults With Acute, Uncomplicated Influenza

MedImmune LLC·interventional·Posted Nov 13, 2015·Updated Jun 8, 2018

In Brief

A Phase 2 clinical trial evaluating Oseltamivir, MEDI8852, and 1 other intervention for Influenza. Completed, enrolled 126 participants across 31 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesSouth Africa, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 13, 2015
Enrollment StartDec 7, 2015
Primary CompletionDec 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.6 years ago

Interventions

Oseltamivirdrug

75 mg capsules orally BID from Day 1 to Day 5.

MEDI8852drug

MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.

Placebodrug

Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.