Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
|ClinicalTrials.gov Identifier: NCT01594437|
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : March 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections||Biological: TCN-202 Biological: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2013|
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
- Number and severity of adverse events [ Time Frame: 60 days post infusion ]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 ]
- Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity) [ Time Frame: 60 days post infusion ]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 ]
- Time to maximum serum concentration (Tmax) of TCN-202 [ Time Frame: 1 day post infusion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594437
|United States, Maryland|
|SNBL Clinical Pharmacology Center|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Mohamed Al-Ibrahim, MD, FACP||SNBL Clinical Pharmacology Center|