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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | SNBL Clinical Pharmacology Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Theraclone Sciences, Inc. |
United States,
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
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 |
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