Influenza Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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