NCT01594437

Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Theraclone Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
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.
BIOLOGICAL	Placebo	One or two doses administered by intravenous infusion.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2012-05-09
• Last updated: 2014-03-21

Locations

1 site across 1 country: United States