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Sponsors and Collaborators: |
Cangene Corporation Department of Health and Human Services |
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Information provided by: | Cangene Corporation |
ClinicalTrials.gov Identifier: | NCT00448253 |
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.
Condition | Intervention | Phase |
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Symptoms of Inhalational Anthrax |
Biological: NP-015 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous (Human), NP-015, in Healthy Volunteers. |
Estimated Enrollment: | 92 |
Study Start Date: | July 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA. And a Fourth Cohort at 840 units TNA with 2 additional product lots.
|
Biological: NP-015
Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo. And a Fourth Cohort at 840 units TNA with 2 additional product lots. |
2: Placebo Comparator
Saline (equal volume to 210 U, 420 U, or 840 U TNA dose)
|
Biological: NP-015
Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo. And a Fourth Cohort at 840 units TNA with 2 additional product lots. |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cangene Corp. ( Fran Yadao, Manager Clinical Operations ) |
Study ID Numbers: | AX-001 |
Study First Received: | March 14, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00448253 |
Health Authority: | United States: Food and Drug Administration |
Inhalational Anthrax Human Immune globulin |
Bacterial Infections Antibodies Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Anthrax Healthy Pneumonia Immunoglobulins |
Immunologic Factors Bacillaceae Infections Physiological Effects of Drugs Pharmacologic Actions |