NCT01756950

Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CR8020, a Monoclonal Antibody Against Influenza A Viruses, Following Single-Dose and Repeat-Dose Intravenous Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal antibody against influenza A viruses.

Detailed description

This randomized, double-blind, placebo-controlled dose escalation study will enroll up to 5 cohorts of healthy subjects. Eight subjects will be enrolled in each cohort and will receive a single 2-hour intravenous infusion of CR8020 (6 subjects) or placebo (2 subjects) on Day 1. Subjects will be dosed in pairs of two. Once all subjects in a cohort have completed Study Day 8, the preliminary safety data will be reviewed. Provided that no safety issues are identified, dose escalation to the subsequent cohort may be permitted. After the completion of Cohort 5 enrollment, and the preliminary safety and tolerability of the 50mg/kg dose is demonstrated, a sixth cohort will be enrolled. Cohort 6 will be comprised of 24 subjects (randomized 5:1 to CR8020 30 mg/kg or placebo) who will receive 2-hour intravenous infusions on Days 1 and 8.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	2 mg/kg CR8020	administered as a single 2-hour intravenous infusion
BIOLOGICAL	5 mg/kg CR8020	administered as a single 2-hour intravenous infusion
BIOLOGICAL	15 mg/kg CR8020	administered as a single 2-hour intravenous infusion
BIOLOGICAL	30 mg/kg CR8020	administered as a single 2-hour intravenous infusion
BIOLOGICAL	50 mg/kg CR8020	administered as a single 2-hour intravenous infusion
BIOLOGICAL	Placebo	administered as a single 2-hour intravenous infusion

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-12-28
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States