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| ID | Type | Description | Link |
|---|---|---|---|
| W911NF-11-C-0029 | Other Grant/Funding Number | W911NF-11-C-0029 |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.
Primary -
- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as compared with Placebo
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FGI-101-1A6 | Experimental | Intervention: Drug-FGI-101-1A6 |
|
| Placebo | Placebo Comparator | Intervention: Drug-Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FGI-101-1A6 | Drug | anti-TSG101 human monoclonal antibody, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments | Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 60, or the early withdrawal, if applicable | 60 days following infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic analysis (PK) | PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6 | 60 days following infusion |
| Immunogenicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melinda Roberson | Contact | 410-706-8877 | mroberson@snbl-pc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation
| From day 1 up to day 60 following infusion |
| D012140 | Respiratory Tract Diseases |