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AIGIV /kg

Phase 1

Anthrax | Monoclonal antibody | Other |Emergent BioSolutions Inc.|Last Updated: Mar 18, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00845650Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)PHASE1 COMPLETED 129 — — Feb 1, 2009Oct 1, 2010Mar 18, 20241 United States
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Study Endpoints
Primary Endpoints
Number of Participants Reporting Adverse Events (AEs)
From the time of infusion through Day 90.

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).

Secondary Endpoints
Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)
From the time of infusion through Day 90 postinfusion.
Time of Cmax
From the time of infusion through Day 90 postinfusion.
Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])
From the time of infusion through Day 90 postinfusion.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AIGIV 3.5 mg/kg (Cohort A)EXPERIMENTALAIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 90 mg/kg (Cohort A)OTHERGamunex 90 mg/kg total IgG as a single intravenous infusion.
AIGIV 7.0 mg/kg (Cohort B)EXPERIMENTALAIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 180 mg/kg (Cohort B)OTHERGamunex 180 mg/kg total IgG as a single intravenous infusion.
AIGIV 14.0 mg/kg (Cohort C)EXPERIMENTALAIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 360 mg/kg (Cohort C)OTHERGamunex 360 mg/kg total IgG as a single intravenous infusion.
Interventions
NameTypeDescription
AIGIV 3.5 mg/kgBIOLOGICALAIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 90 mg/kgBIOLOGICALGamunex 90 mg/kg total IgG as a single intravenous infusion.
AIGIV 7.0 mg/kgBIOLOGICALAIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 180 mg/kgBIOLOGICALGamunex 180 mg/kg total IgG as a single intravenous infusion.
AIGIV 14.0 mg/kgBIOLOGICALAIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 360 mg/kgBIOLOGICALGamunex 360 mg/kg total IgG as a single intravenous infusion.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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