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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

NCT02114268 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2016-11-28

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

MEDI8897 Intravenous

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

DRUG

Placebo

Participants received placebo on Day 1.

DRUG

MEDI8897 Intravenous

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

DRUG

MEDI8897 Intravenous

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

DRUG

MEDI8897 Intramuscular

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

DRUG

MEDI8897 Intramuscular

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • M. Pamela Griffin, MD · MedImmune LLC

  • Martin Kankam, MD, PhD, MPH · Study Site

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02114268 on ClinicalTrials.gov