Phase 1 BA Study, Single Center With Healthy Volunteers
NCT ID: NCT00870948
Last Updated: 2010-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Regimen A
One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Regimen B
One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected IV in an arm vein
ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Regimen C
One 100 mg ABT 874 (reconstituted lyophilized powder from the 3000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Regimen D
One 100 mg ABT-874 (reconstituted lyophilized powder from the 1000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Regimen E
700 mg ABT-874 (reconstituted lyophilized powder from the 3000 L process) in 100 mL 5% dextrose solution IV infusion in an arm vein
ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Interventions
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ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
ALL
Yes
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Joaquin Valdes, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator # 16001
Evansville, Indiana, United States
Countries
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Other Identifiers
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M10-220
Identifier Type: -
Identifier Source: org_study_id