Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease



Status:Completed
Conditions:Healthy Studies, Parkinsons Disease
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:40 - 80
Updated:12/24/2017
Start Date:July 1, 2015
End Date:November 20, 2017

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A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease

The primary objective of the study is to evaluate the safety and tolerability of a range of
single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy
participants and participants with early Parkinson's disease (PD). Secondary objectives of
the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose
administration and to evaluate the immunogenicity of BIIB054 after single-dose
administration.

Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with
early PD will be enrolled in Cohort 7

Key Inclusion Criteria:

1. All women of childbearing potential and all men must practice effective contraception
during the study and for 6 months after their last dose of study treatment.

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

Key Exclusion Criteria:

1. History of cardiovascular disease.

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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
9
sites
Hallandale Beach, Florida 33009
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Cleveland, OH
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Dallas, TX
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Durham, NC
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Evansville, IN
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Farmington Hills, Michigan 48334
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Farmington Hills, MI
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Oviedo, FL
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Spokane, WA
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Washington,
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