Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 5/3/2014 |
| Start Date: | May 2012 |
| End Date: | February 2013 |
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.
single or multiple intravenous administrations of TCN-202 as compared with placebo.
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.
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.
Inclusion Criteria:
- Healthy adult volunteers
- Normal lab tests
Exclusion Criteria:
- Prior treatment with monoclonal antibody
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