Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theraclone Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01594437
First received: May 5, 2012
Last updated: March 19, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 48
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594437

Locations
United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
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: March 19, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014