Trial | NCT01390025  Report issue

Title

Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza
Phase 1 Study of TCN-032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Healthy Adult Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tcn-032 ...

  • Study Participants

    40
The purpose of this study is to compare the safety profile in healthy volunteers of a single intravenous administration of TCN-032 as compared with placebo.
Influenza is a highly communicable acute respiratory disease that is considered to be one of the major infectious disease threats to the human population. Annual vaccination is generally effective only against those strains included in the vaccine. Because of the frequent emergence of divergent variants and the periodic emergence of strains with novel hemagglutinin and/or neuraminidase surface proteins that can result in global pandemics, the availability of potent antiviral agents for the prevention and/or treatment of influenza remains an urgent clinical and public health priority.
Study Started
Sep 30
2011
Primary Completion
Mar 31
2012
Study Completion
Mar 31
2012
Last Update
Apr 02
2012
Estimate

Biological TCN-032

TCN-032 is a human monoclonal antibody that specifically binds to a conserved epitope of the amino-terminal extracellular domain (M2e) of the influenza virus matrix protein 2 (M2). The drug is intended for use as an antiviral agent for the treatment of disease caused by type A influenza viruses. Treatments within the study will consist of single ascending dose-escalation ranging from 1 to 40 mg/kg.

Biological Placebo

Placebo - 0.9% Sodium Chloride for Injection, USP

TCN-032 Experimental

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

Healthy volunteers
Normal lab tests

Exclusion Criteria:

Prior treatment with a monoclonal antibody
No Results Posted