NCT01406418

Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CR6261, a Monoclonal Antibody Against Influenza A Viruses, Following Single-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 CR6261, a monoclonal antibody against influenza A viruses.

Detailed description

This randomized, double-blind, placebo-controlled dose escalation study will enroll up to 6 cohorts of healthy subjects. Eight subjects will be enrolled in each cohort (1 to 5) and will receive a single 2-hour intravenous infusion of CR6261 (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. To obtain additional data at the 30 mg/kg dose level, a sixth cohort will be enrolled after the preliminary safety and tolerability of the 30 mg/kg dose in Cohort 4 is demonstrated. Cohort 6 will be comprised of 24 subjects (randomized 5 : 1 to CR6261 or placebo) following the same visit schedule as subjects in Cohorts 1-5.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	CR6261 2 mg/kg	Administered as a single 2-hour intravenous infusion
BIOLOGICAL	CR6261 5 mg/kg	Administered as a single 2-hour intravenous infusion
BIOLOGICAL	CR6261 15 mg/kg	Administered as a single 2-hour intravenous infusion
BIOLOGICAL	CR6261 30 mg/kg	Administered as a single 2-hour intravenous infusion
BIOLOGICAL	CR6261 50 mg/kg	Administered as a single 2-hour intravenous infusion
BIOLOGICAL	Placebo	Administered as a single 2-hour intravenous infusion

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-08-01
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States