Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cytomegalovirus Infections

Intervention / Treatment
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* Biological: TCN-202
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers Normal lab tests Exclusion Criteria: Prior treatment with monoclonal antibody

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCN-202<br> | Biological: TCN-202<br>* Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.<br>* Other names: Human Anti-Cytomegalovirus Monoclonal Antibody;|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* One or two doses administered by intravenous infusion.<br>* Other names: 0.9% Sodium chloride for Injection, USP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of adverse events | Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis). | 60 days post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak serum concentration (Cmax) of TCN-202 |  | 1 day post infusion | 
| Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity) | Immunogenicity will be assessed based on induction of TCN-202 anti-drug antibodies. | 60 days post infusion | 
| Area under the concentration time curve (AUC) of TCN-202 |  | 60 days post infusion | 
| Time to maximum serum concentration (Tmax) of TCN-202 |  | 1 day post infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytomegalovirus, Monoclonal antibody