Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AIGIV/kg · 1 trial · 1 indication
Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).
| Arm | Type | Description |
|---|---|---|
| AIGIV 3.5 mg/kg (Cohort A) | EXPERIMENTAL | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 90 mg/kg (Cohort A) | OTHER | Gamunex 90 mg/kg total IgG as a single intravenous infusion. |
| AIGIV 7.0 mg/kg (Cohort B) | EXPERIMENTAL | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 180 mg/kg (Cohort B) | OTHER | Gamunex 180 mg/kg total IgG as a single intravenous infusion. |
| AIGIV 14.0 mg/kg (Cohort C) | EXPERIMENTAL | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 360 mg/kg (Cohort C) | OTHER | Gamunex 360 mg/kg total IgG as a single intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| AIGIV 3.5 mg/kg | BIOLOGICAL | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 90 mg/kg | BIOLOGICAL | Gamunex 90 mg/kg total IgG as a single intravenous infusion. |
| AIGIV 7.0 mg/kg | BIOLOGICAL | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 180 mg/kg | BIOLOGICAL | Gamunex 180 mg/kg total IgG as a single intravenous infusion. |
| AIGIV 14.0 mg/kg | BIOLOGICAL | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 360 mg/kg | BIOLOGICAL | Gamunex 360 mg/kg total IgG as a single intravenous infusion. |
Inclusion Criteria: * Between 18 and 65 years of age, inclusive. * Have a minimal weight of 110 lbs and a body mass index (BMI) between 17 and 35. * In good health. * For pre-menopausal female subjects, using acceptable methods of birth control. * Willing and capable of complying with all aspects o...
AIGIV/kg is an investigational therapy being developed for anthrax. It is a monoclonal antibody product studied in healthy adult volunteers to evaluate safety and pharmacokinetics. It is not an approved treatment and remains in clinical development.
AIGIV/kg is being developed by Emergent BioSolutions Inc., which trades on the New York Stock Exchange under the ticker EBS. The company sponsored the clinical study of the product in anthrax.
AIGIV/kg is in Phase 1 clinical development. The program has completed one Phase 1 trial and has no active trials. It is investigational and has not been approved by the FDA for any indication.
AIGIV/kg has been studied in one completed Phase 1 trial, NCT00845650, titled Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV). The trial enrolled 129 healthy adult volunteers in the United States and used a randomized, double-blind, controlled design.