Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza

Theraclone Sciences

Status and phase: Completed; Phase 1

Conditions: Influenza, Human

Treatments: Biological: TCN-032; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01390025

TCN-032-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Normal lab tests

Exclusion criteria

• Prior treatment with a monoclonal antibody

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

TCN-032

Experimental group

Treatment:

Biological: TCN-032

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo