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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00636519 | Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle | PHASE1 | COMPLETED | 36 | — | — | Feb 1, 2008 | Oct 1, 2009 | Mar 18, 2024 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Stage A | EXPERIMENTAL | Botulism Antitoxin Bivalent (Equine) Types A and B Vs. Placebo |
| Stage B | EXPERIMENTAL | Botulism Antitoxin Heptavalent (Equine) Types A-G Vs. Placebo |
| Name | Type | Description |
|---|---|---|
| Botulism Antitoxin Bivalent (Equine) Types A and B | BIOLOGICAL | One vial of Botulism Antitoxin Bivalent(Equine) Types A and B (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage A |
| Botulism Antitoxin Heptavalent (Equine) Types A-G | BIOLOGICAL | One vial of Heptavalent Botulism Antitoxin (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage B |
Inclusion Criteria: * Male or female * Age 18 - 55 years * Body-mass index 19-30 * Normal and healthy as determined by medical history, physical examination, ECG, NCS, vital signs and tests of liver, kidney and hematological functions * Adequate form of contraception for female subjects * For wo...