Back to resultsSafety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TCN-202
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring Cytomegalovirus, Monoclonal antibody
Eligibility Criteria
Inclusion Criteria:
- Healthy adult volunteers
- Normal lab tests
Exclusion Criteria:
- Prior treatment with monoclonal antibody
Sites / Locations
- SNBL Clinical Pharmacology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TCN-202
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Peak serum concentration (Cmax) of TCN-202
Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)
Immunogenicity will be assessed based on induction of TCN-202 anti-drug antibodies.
Area under the concentration time curve (AUC) of TCN-202
Time to maximum serum concentration (Tmax) of TCN-202
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01594437
Brief Title
Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
Official Title
Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theraclone Sciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
Keywords
Cytomegalovirus, Monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCN-202
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
TCN-202
Other Intervention Name(s)
Human Anti-Cytomegalovirus Monoclonal Antibody
Intervention Description
Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% Sodium chloride for Injection, USP
Intervention Description
One or two doses administered by intravenous infusion.
Primary Outcome Measure Information:
Title
Number and severity of adverse events
Description
Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).
Time Frame
60 days post infusion
Secondary Outcome Measure Information:
Title
Peak serum concentration (Cmax) of TCN-202
Time Frame
1 day post infusion
Title
Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)
Description
Immunogenicity will be assessed based on induction of TCN-202 anti-drug antibodies.
Time Frame
60 days post infusion
Title
Area under the concentration time curve (AUC) of TCN-202
Time Frame
60 days post infusion
Title
Time to maximum serum concentration (Tmax) of TCN-202
Time Frame
1 day post infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult volunteers
Normal lab tests
Exclusion Criteria:
Prior treatment with monoclonal antibody
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Al-Ibrahim, MD, FACP
Organizational Affiliation
SNBL Clinical Pharmacology Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNBL Clinical Pharmacology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
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