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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedApril 2, 2012
March 1, 2012
6 months
July 5, 2011
March 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032
60 days post infusion
Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032
60 days post infusion
Study Arms (2)
TCN-032
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Normal lab tests
You may not qualify if:
- Prior treatment with a monoclonal antibody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201, United States
Related 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.
PMID: 20615945BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed Al-Ibrahim, MD, FACP
SNBL
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 8, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 2, 2012
Record last verified: 2012-03