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

Influenza, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390025
• Other study ID #: TCN-032-001
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2011
• Last updated: March 30, 2012
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Theraclone Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Normal lab tests

Exclusion Criteria:

• Prior treatment with a monoclonal antibody

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza, Human

Intervention

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.
• Placebo
Placebo - 0.9% Sodium Chloride for Injection, USP

Locations

Country	Name	City	State
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Theraclone Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Grandea AG 3rd, Olsen OA, Cox TC, Renshaw M, Hammond PW, Chan-Hui PY, Mitcham JL, Cieplak W, Stewart SM, Grantham ML, Pekosz A, Kiso M, Shinya K, Hatta M, Kawaoka Y, Moyle M. Human antibodies reveal a protective epitope that is highly conserved among human and nonhuman influenza A viruses. Proc Natl Acad Sci U S A. 2010 Jul 13;107(28):12658-63. doi: 10.1073/pnas.0911806107. Epub 2010 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment - number of participants with adverse events (AE)	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	60 days post infusion	Yes
Secondary	Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032	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).	60 days post infusion	No
Secondary	Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032	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.	60 days post infusion	No