Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Cytomegalovirus Infections

Clinical Trial Details

NCT number	NCT01594437
Study type	Interventional
Source	Theraclone Sciences, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	May 2012
Completion date	March 2013

View Details

See also
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