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Completed

NCT Number: NCT01594437

Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

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.

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Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteers
  • Normal lab tests

Exclusion criteria

  • Prior treatment with monoclonal antibody

Treatment and study plan

TCN-202

Biological

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

Placebo

Biological

One or two doses administered by intravenous infusion.

Other names: 0.9% Sodium chloride for Injection, USP

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Theraclone Sciences, Inc.

Industry

Registry information

Official study title

Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
May 9, 2012
Registry last updated
Mar 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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