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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MedImmune LLC

Criteria

Key Inclusion Criteria:

• Age 18 through 49 years and in good health by history, physical exam, and labs

• Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at Screening

• Written informed consent prior to performing any protocol related procedures, including Screening evaluations

• Ability to complete the Follow-up period of 360 days

Key Exclusion Criteria:

• Acute illness including fever >= 99.5 Fahrenheit (°F) on day of dosing

• Any drug therapy within 7 days prior to Day 1 (except contraceptives)

• Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing

• Previous receipt of a monoclonal antibody (mAb)

• Pregnant or nursing mother

• Concurrent enrollment in another interventional study