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

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

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 40 - 80 Status: Completed
Time Since Diagnosis: Less than 5 years Study Focus: Neuroprotection

Study Purpose:

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.

More Details

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

Phase: Phase 1 Lead Sponsor: Biogen
Trial ID: 004156 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors:
Estimated Enrollment: 66 Study Start Date:
Estimated Study Completion Date: June 2017 Source:
Study Website:
This is a FDA Regulated Trial

More Inclusion & Exclusion Criteria

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