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A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza

NCT02603952 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2018-06-08

Study results available
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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.

Conditions

Interventions

DRUG

Oseltamivir

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

DRUG

MEDI8852

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

DRUG

Placebo

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-07
Primary Completion
2016-12-09
Completion
2016-12-09

Countries

  • United States
  • South Africa

Study Locations

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Entities

Drugs
Diseases

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 NCT02603952 on ClinicalTrials.gov