Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
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 May 2012
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
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 5, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 21, 2014
March 1, 2014
7 months
May 5, 2012
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and severity of adverse events
Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).
60 days post infusion
Secondary Outcomes (4)
Peak serum concentration (Cmax) of TCN-202
1 day post infusion
Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)
60 days post infusion
Area under the concentration time curve (AUC) of TCN-202
60 days post infusion
Time to maximum serum concentration (Tmax) of TCN-202
1 day post infusion
Study Arms (2)
TCN-202
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.
One or two doses administered by intravenous infusion.
Eligibility Criteria
You may qualify if:
- Healthy adult volunteers
- Normal lab tests
You may not qualify if:
- Prior treatment with monoclonal antibody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed Al-Ibrahim, MD, FACP
SNBL Clinical Pharmacology Center
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
May 5, 2012
First Posted
May 9, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
March 21, 2014
Record last verified: 2014-03