Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers|
- Number and severity of adverse events [ Time Frame: 60 days post infusion ] [ Designated as safety issue: Yes ]Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).
- Peak serum concentration (Cmax) of TCN-202 [ Time Frame: 1 day post infusion ] [ Designated as safety issue: No ]
- Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity) [ Time Frame: 60 days post infusion ] [ Designated as safety issue: No ]Immunogenicity will be assessed based on induction of TCN-202 anti-drug antibodies.
- Area under the concentration time curve (AUC) of TCN-202 [ Time Frame: 60 days post infusion ] [ Designated as safety issue: No ]
- Time to maximum serum concentration (Tmax) of TCN-202 [ Time Frame: 1 day post infusion ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.
Other Name: Human Anti-Cytomegalovirus Monoclonal Antibody
|Placebo Comparator: Placebo||
One or two doses administered by intravenous infusion.
Other Name: 0.9% Sodium chloride for Injection, USP
Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is ~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection. As existing therapies for HCMV can have serious side effects, there remains a medical need for safe and effective treatment of HCMV disease.
|United States, Maryland|
|SNBL Clinical Pharmacology Center|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Mohamed Al-Ibrahim, MD, FACP||SNBL Clinical Pharmacology Center|