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

Phase 1

Completed

• Conditions: Influenza, Human
• Interventions: Biological: TCN-032; Biological: Placebo

• Registration Number: NCT01390025
• Lead Sponsor: Theraclone Sciences, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Study Start: 2011-09
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy volunteers
• Normal lab tests

Exclusion Criteria

• Prior treatment with a monoclonal antibody

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCN-032	TCN-032	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety assessment - number of participants with adverse events (AE)	60 days post infusion	Safety will be assessed by physical examinations, vital signs, serial electrocardiograms and clinical laboratory tests (hematology, chemistry and urinalysis). A clinically significant laboratory value will be any abnormal result that is an unexpected or unexplained laboratory value or change in value from the patient's prior values. AEs will be reported by severity and relatedness to study treatment and classified according to MedDRA

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032	60 days post infusion	PK evaluation of TCN-032 plasma concentrations will include: tmax (time at which maximum concentration is observed),Cmax (maximum observed concentration), t1/2 (terminal-elimination half-life), CL (clearance), Vd (volume of distribution).
Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032	60 days post infusion	Immunogenicity will be assessed based on induction of TCN-032 anti-drug antibodies. Baseline and serial post-treatment serum measures of anti-TCN-032 antibodies will be detected by immunoassay and summarized by dose and time point with means, standard deviations, medians, quartiles, and ranges. Change from baseline in anti-TCN-032 antibody levels will be similarly analyzed.

Trial Locations

Locations (1)

SNBL Clinical Pharmacology Center; 🇺🇸 Baltimore, Maryland, United States