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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Assessment of antibodies binding to CR6261 as a measure of immunogenicity of single escalating doses of CR6261(From baseline to 75 days post-dose)
• Assessment of pharmacokinetics of single escalating doses of CR6261(From baseline to 75 days post-dose)