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Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594437
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : March 21, 2014
Sponsor:
Information provided by (Responsible Party):
Theraclone Sciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Biological: TCN-202 Biological: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TCN-202 Biological: 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 Name: Human Anti-Cytomegalovirus Monoclonal Antibody
Placebo Comparator: Placebo Biological: Placebo
One or two doses administered by intravenous infusion.
Other Name: 0.9% Sodium chloride for Injection, USP


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Peak serum concentration (Cmax) of TCN-202 [ Time Frame: 1 day post infusion ]
  2. 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.

  3. Area under the concentration time curve (AUC) of TCN-202 [ Time Frame: 60 days post infusion ]
  4. Time to maximum serum concentration (Tmax) of TCN-202 [ Time Frame: 1 day post infusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult volunteers
  • Normal lab tests

Exclusion Criteria:

  • Prior treatment with monoclonal antibody
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Theraclone Sciences, Inc.
Investigators
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Principal Investigator: Mohamed Al-Ibrahim, MD, FACP SNBL Clinical Pharmacology Center
More Information
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Responsible Party: Theraclone Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01594437    
Other Study ID Numbers: TCN-202-001
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014
Keywords provided by Theraclone Sciences, Inc.:
Cytomegalovirus
Monoclonal antibody
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs