- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594437
Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
March 19, 2014 updated by: Theraclone Sciences, Inc.
Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- SNBL Clinical Pharmacology Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult volunteers
- Normal lab tests
Exclusion Criteria:
- Prior treatment with monoclonal antibody
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
One or two doses administered by intravenous infusion.
Other Names:
|
Experimental: TCN-202
|
Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV.
One or two doses will be administered by intravenous infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
60 days post infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak serum concentration (Cmax) of TCN-202
Time Frame: 1 day post infusion
|
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.
|
60 days post infusion
|
Area under the concentration time curve (AUC) of TCN-202
Time Frame: 60 days post infusion
|
60 days post infusion
|
|
Time to maximum serum concentration (Tmax) of TCN-202
Time Frame: 1 day post infusion
|
1 day post infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Al-Ibrahim, MD, FACP, SNBL Clinical Pharmacology Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 5, 2012
First Submitted That Met QC Criteria
May 8, 2012
First Posted (Estimate)
May 9, 2012
Study Record Updates
Last Update Posted (Estimate)
March 21, 2014
Last Update Submitted That Met QC Criteria
March 19, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCN-202-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cytomegalovirus Infections
-
University of Alabama at BirminghamEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingMaternal Cytomegalovirus Infections | Cytomegalovirus CongenitalUnited States
-
University of Sao Paulo General HospitalCompletedCytomegalovirus DiseaseBrazil
-
Mayo ClinicCompletedCytomegalovirus InfectionUnited States
-
Merck Sharp & Dohme LLCCompletedCytomegalovirus InfectionUnited States, France, Germany, Italy, Japan, United Kingdom
-
Assistance Publique - Hôpitaux de ParisCompletedCongenital Cytomegalovirus InfectionFrance
-
National Institute of Allergy and Infectious Diseases...Terminated
-
Institut PasteurCompletedCongenital Cytomegalovirus InfectionFrance
-
Merck Sharp & Dohme LLCCompletedCytomegalovirus (CMV) InfectionsUnited States, Australia, Canada, Finland, Israel, Russian Federation, Spain
-
Assistance Publique - Hôpitaux de ParisCompletedCongenital Cytomegalovirus InfectionFrance
-
The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedCongenital Cytomegalovirus Infection | Maternal Cytomegalovirus InfectionUnited States
Clinical Trials on TCN-202
-
Prescient Therapeutics, Ltd.VioQuest PharmaceuticalsCompleted
-
Devalingam MahalingamGenSpera, Inc.No longer availableHepatocellular Carcinoma
-
GenSpera, Inc.WithdrawnProstate Cancer.United States
-
Prescient Therapeutics, Ltd.VioQuest PharmaceuticalsCompletedLeukemia | Hematologic MalignanciesUnited States
-
Immune-Onc TherapeuticsCalifornia Institute for Regenerative Medicine (CIRM)RecruitingCMML | AML With Monocytic DifferentiationUnited States
-
Evofem Inc.Neothetics, IncTerminatedCentral Abdominal Bulging
-
GenSpera, Inc.Saint John's Cancer InstituteWithdrawn
-
Shanghai Zerun Biotechnology Co.,LtdWalvax Biotechnology Co., Ltd.Active, not recruiting
-
Prescient Therapeutics, Ltd.Terminated
-
REGENXBIO Inc.RecruitingDuchenne Muscular DystrophyUnited States