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Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

This study is currently recruiting participants.
Verified May 2012 by Theraclone Sciences, Inc.
Sponsor:
Information provided by (Responsible Party):
Theraclone Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01594437
First received: May 5, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Cytomegalovirus Infections
 Biological: TCN-202
Biological: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Theraclone Sciences, Inc.:

Primary Outcome Measures:
  • Number and severity of adverse events [ Time Frame: 60 days post infusion ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 day post infusion ] [ Designated as safety issue: No ]
  • Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity) [ Time Frame: 60 days post infusion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to maximum serum concentration (Tmax) of TCN-202 [ Time Frame: 1 day post infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: May 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult volunteers
  • Normal lab tests

Exclusion Criteria:

  • Prior treatment with monoclonal antibody
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594437

Locations
United States, Maryland
SNBL Clinical Pharmacology Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Melinda Roberson, PhD     410-706-8772        
Principal Investigator: Mohamed Al-Ibrahim, MD, FACP            
Sponsors and Collaborators
Theraclone Sciences, Inc.
Investigators
Principal Investigator: Mohamed Al-Ibrahim, MD, FACP SNBL Clinical Pharmacology Center
  More Information

No publications provided

Responsible Party: Theraclone Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01594437     History of Changes
Other Study ID Numbers: TCN-202-001
Study First Received: May 5, 2012
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Theraclone Sciences, Inc.:
Cytomegalovirus
Monoclonal antibody

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antibodies
 Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013