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

NCT01390025 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Influenza, Human

Interventions

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

Sponsors & Collaborators

  • Theraclone Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MD, FACP · SNBL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01390025 on ClinicalTrials.gov