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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 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 129 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00845650
The ClinicalTrials.gov registry entry for NCT00845650 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which AIGIV 3.5 mg/kg is the first listed.
NCT00845650 reports 0 study locations.
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.
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