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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 09-0008 | Other Grant/Funding Number | HHSN272200800040C |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Primary:
• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo
Secondary:
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVP-21D9 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVP-21D9 | Drug | intravenously, single dose |
| |
| Placebo |
| 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 90 or the early withdrawl visit, if applicable. | 90 days following infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) analysis | PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9. | 90 days following infusion |
| Immunogenicity analysis |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hopkins, MD | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Development Solutions | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24733473 | Derived | Malkevich NV, Hopkins RJ, Bernton E, Meister GT, Vela EM, Atiee G, Johnson V, Nabors GS, Aimes RT, Ionin B, Skiadopoulos MH. Efficacy and safety of AVP-21D9, an anthrax monoclonal antibody, in animal models and humans. Antimicrob Agents Chemother. 2014 Jul;58(7):3618-25. doi: 10.1128/AAC.02295-13. Epub 2014 Apr 14. |
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| ID | Term |
|---|---|
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000601130 | AVP-21D9 |
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| Drug |
Placebo comparator |
|
|
Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation
| From day 1 up to day 90 following infusion |
| D007239 | Infections |