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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCN-202 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCN-202 | Biological | Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Al-Ibrahim, MD, FACP | SNBL Clinical Pharmacology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Placebo | Biological | One or two doses administered by intravenous infusion. |
|
|
| 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 |
| D017670 |
| Sodium Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |