Status:
COMPLETED
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
25-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.
Detailed Description
All subjects will be screened for eligibility after providing signed informed consent. Once a subject is determined to be eligible, the subject will be vaccinated with the quadrivalent meningococcal c...
Eligibility Criteria
Inclusion
- Healthy individuals 25 to 55 years of age with documented vaccination with MCV4.
Exclusion
- Abnormal renal or liver function.
- History of meningococcal disease.
- History of Guillain-Barre syndrome.
- Known infection with HIV or Hepatitis B or C.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01454986
Start Date
November 1 2011
End Date
October 1 2013
Last Update
February 3 2017
Active Locations (1)
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1
PAREXEL Baltimore EPCU
Baltimore, Maryland, United States, 21225