Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

Theraclone Sciences

Status and phase: Completed; Phase 1

Conditions: Cytomegalovirus Infections

Treatments: Biological: TCN-202; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594437

TCN-202-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteers
• Normal lab tests

Exclusion criteria

• Prior treatment with monoclonal antibody

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

TCN-202

Experimental group

Treatment:

Biological: TCN-202

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo