Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01454986 |
Date of registration:
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07/10/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
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Scientific title:
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A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ALXN1007 in Healthy Subjects |
Date of first enrolment:
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November 2011 |
Target sample size:
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64 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01454986 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy individuals 25 to 55 years of age with documented vaccination with MCV4.
Exclusion Criteria:
- Abnormal renal or liver function.
- History of meningococcal disease.
- History of Guillain-Barre syndrome.
- Known infection with HIV or Hepatitis B or C.
Age minimum:
25 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Other: Placebo
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Drug: ALXN1007
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Primary Outcome(s)
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Safety and tolerability of a single dose of ALXN1007.
[Time Frame: Up to 90 days]
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Secondary Outcome(s)
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PD parameters of ALXN1007
[Time Frame: Up to 90 days]
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PK parameters of ALXN1007
[Time Frame: Up to 90 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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