Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01202695 | Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9) | PHASE1 | COMPLETED | 50 | — | — | Aug 1, 2010 | Jun 1, 2011 | Mar 15, 2024 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| AVP-21D9 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AVP-21D9 | DRUG | intravenously, single dose |
| Placebo | DRUG | Placebo comparator |
Key Inclusion Criteria: * Healthy volunteers, between 18 and 45 years of age * Normal laboratory (blood test) results Key Exclusion Criteria: * Prior immunization with anthrax vaccine