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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

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.

This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.

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