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

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:
  • 0.9% Sodium chloride for Injection, USP
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:
  • Human Anti-Cytomegalovirus Monoclonal Antibody

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.

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

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.

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