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NCT00845650 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 129
- Enrollment target
NCT00845650: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT00845650 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 129 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00845650, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 129 participants
- Enrollment target
Study Summary
The purpose of this study is to: * evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360 mg/kg total IgG, GAMUNEX® (immune globulin intravenous (human) 10% caprylate/chromatography purified). GAMUNEX is a trademark of Talecris Biotherapeutics. * evaluate the pharmacokinetic (PK) profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as measured by lethal toxin neutralizing antibody (TNA).
Primary Outcome
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).
Interventions
- BIOLOGICAL AIGIV 3.5 mg/kg
- BIOLOGICAL Gamunex 90 mg/kg
- BIOLOGICAL AIGIV 7.0 mg/kg
- BIOLOGICAL Gamunex 180 mg/kg
- BIOLOGICAL AIGIV 14.0 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00845650 record still lists
NCT00845650 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher).
The record links to 0 conditions, and to 5 interventions - of which AIGIV 3.5 mg/kg is the first listed.
NCT00845650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00845650 about?
NCT00845650 is a clinical study titled "Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)". The purpose of this study is to: * evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360 mg/kg total IgG, GAMUNEX® (immune globulin intravenous (human) 10% cap...
What is the current status of trial NCT00845650?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2009-02. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00845650?
The interventions under investigation include: AIGIV 3.5 mg/kg (BIOLOGICAL), Gamunex 90 mg/kg (BIOLOGICAL), AIGIV 7.0 mg/kg (BIOLOGICAL), Gamunex 180 mg/kg (BIOLOGICAL), AIGIV 14.0 mg/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00845650?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00845650's enrollment target sits among peer trials
129 451st of 2000 higher than 1,549 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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