Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
NCT ID: NCT02459886
Last Updated: 2019-08-08
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
66 participants
INTERVENTIONAL
2015-07-01
2017-11-20
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
QUADRUPLE
Study Groups
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Cohort 1
Single intravenous (IV) low dose infusion with staggered participant dosing
BIIB054
IV infusion
Placebo
IV infusion
Cohort 2
Single IV ascending dose infusion with staggered participant dosing
BIIB054
IV infusion
Placebo
IV infusion
Cohort 3
Single IV ascending dose infusion with staggered participant dosing
BIIB054
IV infusion
Placebo
IV infusion
Cohort 4
Single IV ascending dose infusion with staggered participant dosing
BIIB054
IV infusion
Placebo
IV infusion
Cohort 5
Single IV ascending dose infusion with staggered participant dosing
BIIB054
IV infusion
Placebo
IV infusion
Cohort 6
Single IV ascending dose infusion with staggered participant dosing
BIIB054
IV infusion
Placebo
IV infusion
Cohort 7
Single IV ascending dose infusion with staggered participant dosing
BIIB054
IV infusion
Placebo
IV infusion
Interventions
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BIIB054
IV infusion
Placebo
IV infusion
Eligibility Criteria
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Inclusion Criteria
2. Must have a body mass index from 19 to 32 kg/m2, inclusive.
3. Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
For cohort 7 only:
4. Diagnosis of idiopathic PD
Exclusion Criteria
2. Subject smokes more than 5 cigarettes or the equivalent in tobacco daily.
3. Surgery within 3 months prior to Day -1 (other than minor cosmetic surgery and minor dental surgery, as determined by the Investigator).
4. History or positive test result for hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
5. Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
40 Years
80 Years
ALL
Yes
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Washington D.C., District of Columbia, United States
Research Site
Hallandale, Florida, United States
Research Site
Oviedo, Florida, United States
Research Site
Evansville, Indiana, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Durham, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Dallas, Texas, United States
Research Site
Spokane, Washington, United States
Countries
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Other Identifiers
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228HV101
Identifier Type: -
Identifier Source: org_study_id
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