Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
NCT ID: NCT01454986
Last Updated: 2017-02-03
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
64 participants
INTERVENTIONAL
2011-11-30
2013-10-31
Brief Summary
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Detailed Description
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The subjects will return for 8 additional clinic visits to complete the required study tests over the next 86 days. The total duration of the study is 90 days from the day of dosing with ALXN1007 or placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
0.06 mg/kg ALXN1007
ALXN1007
Single dose, IV
Placebo
Single dose, IV
Cohort 2
0.1 mg/kg ALXN1007
ALXN1007
Single dose, IV
Placebo
Single dose, IV
Cohort 3
0.3 mg/kg ALXN1007
ALXN1007
Single dose, IV
Placebo
Single dose, IV
Cohort 4
1.0 mg/kg ALXN1007
ALXN1007
Single dose, IV
Placebo
Single dose, IV
Cohort 5
3.0 mg/kg ALXN1007
ALXN1007
Single dose, IV
Placebo
Single dose, IV
Cohort 6
6.0 mg/kg ALXN1007
ALXN1007
Single dose, IV
Placebo
Single dose, IV
Cohort 7
10.0 mg/kg ALXN1007
ALXN1007
Single dose, IV
Placebo
Single dose, IV
Interventions
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ALXN1007
Single dose, IV
Placebo
Single dose, IV
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of meningococcal disease.
* History of Guillain-Barre syndrome.
* Known infection with HIV or Hepatitis B or C.
25 Years
55 Years
ALL
Yes
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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PAREXEL Baltimore EPCU
Baltimore, Maryland, United States
Countries
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Other Identifiers
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C11-002
Identifier Type: -
Identifier Source: org_study_id
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