NCT02459886

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Parkinson's Disease
• Healthy

Interventions

Type	Name	Description
DRUG	BIIB054	IV infusion
DRUG	Placebo	IV infusion

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-11-20
• Completion: 2017-11-20
• First posted: 2015-06-02
• Last updated: 2019-08-08

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study