Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT01406418
Brief 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.
Study:
NCT01406418
Study Brief:
Protocol Section:
NCT01406418