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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

NCT02290340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2018-09-19

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

Participants will receive placebo intramuscularly.

DRUG

MEDI8897 10 mg

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

DRUG

MEDI8897 25 mg

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

DRUG

MEDI8897 50 mg

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-13
Primary Completion
2016-09-28
Completion
2016-09-28

Countries

  • United States
  • Chile
  • 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 NCT02290340 on ClinicalTrials.gov