NCT02114268

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-04-15
• Last updated: 2016-11-28
• Results posted: 2016-11-28

Locations

1 site across 1 country: United States