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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00448253 | Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum | PHASE1 | COMPLETED | 92 | — | — | Jul 1, 2007 | Sep 1, 2008 | Mar 15, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA. And a Fourth Cohort at 840 units TNA with 2 additional product lots. |
| 2 | PLACEBO_COMPARATOR | Saline (equal volume to 210 U, 420 U, or 840 U TNA dose) |
| Name | Type | Description |
|---|---|---|
| NP-015 | BIOLOGICAL | Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo. And a Fourth Cohort at 840 units TNA with 2 additional product lots. |
Inclusion Criteria: * Male or female * Age 18/19 (dependent on local age of majority) - 55 years * Body mass index of 19 - 29 * For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including: * Using hormonal contracept...