Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|