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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Assessment of pharmacokinetics of single escalating doses of CR8020(From baseline to 98 days post-dose)
• Assessment of antibodies binding to CR8020 as a measure of immunogenicity of single escalating doses of CR8020(From baseline to 98 days post-dose)