Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus, RSV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 342
Healthy volunteers: yes

Brief 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.

Detailed description:
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.

Arms:
arm 1: Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. arm 2: Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. arm 3: Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. arm 4: Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. arm 5: Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. arm 6: Participants received placebo on Day 1.

Interventions: intervention 1: MEDI8897 Intravenous intervention 2: Placebo intervention 3: MEDI8897 Intravenous intervention 4: MEDI8897 Intravenous intervention 5: MEDI8897 Intramuscular intervention 6: MEDI8897 Intramuscular
Intervention descriptions: intervention 1: Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. intervention 2: Participants received placebo on Day 1. intervention 3: Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. intervention 4: Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. intervention 5: Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. intervention 6: Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Protocol document: