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Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum

OverviewStructured DataIssuesContributors

Contents

clinicaltrials.gov/study/NCT00448253
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT004482530
Trial Recruitment Size
920
Trial Sponsor
Emergent BioSolutions
Emergent BioSolutions
0
Trial Collaborator
‌
Department of health and human services
0
Clinical Trial Start Date
2007
0
Primary Completion Date
2008
0
Study Completion Date
2008
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Intervention Name
NP-0150
Interventional Trial Phase
Phase 10
Participating Facility
‌
MDS Pharma Services
0
Official Name
Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous (Human), NP-015, in Healthy Volunteers0
Last Updated
March 18, 2020
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Participant0
Outcomes Assessor0
Investigator0
Care Provider0
Study summary

The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.

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