Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
NCT ID: NCT02151110
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2014-05-27
2016-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
Placebo
Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
MEDI4920 3 mg
Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
MEDI4920 3 mg
Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
MEDI4920 10 mg
Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
MEDI4920 10 mg
Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
MEDI4920 30 mg
Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
MEDI4920 30 mg
Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
MEDI4920 100 mg
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
MEDI4920 100 mg
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
MEDI4920 300 mg
Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
MEDI4920 300 mg
Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
MEDI4920 1000 mg
Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
MEDI4920 1000 mg
Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
MEDI4920 3000 mg
Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
MEDI4920 3000 mg
Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Interventions
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MEDI4920 3 mg
Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
MEDI4920 10 mg
Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
MEDI4920 30 mg
Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
MEDI4920 100 mg
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
MEDI4920 300 mg
Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
MEDI4920 1000 mg
Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
MEDI4920 3000 mg
Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Placebo
Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
Eligibility Criteria
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Inclusion Criteria
* Body weight 40 to 100 kg
* Body mass index 19.0 to 30.0 kg/m2
Exclusion Criteria
* previous immunization with KLH
* previous splenectomy
* History of diagnosed or suspected thromboembolic event or coagulation disorder
18 Years
49 Years
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Leeds, , United Kingdom
Countries
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Other Identifiers
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D5100C00001
Identifier Type: -
Identifier Source: org_study_id
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