Trials / Terminated
TerminatedNCT03716570
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease
A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of BIIB054, administered as intravenous (IV) infusion, in Japanese participants with Parkinson's disease (PD). The secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (PK) profile of BIIB054 after single and multiple dose administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB054 | Administered as specified in the treatment arm. |
| DRUG | Placebo | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2019-03-12
- Primary completion
- 2021-04-23
- Completion
- 2021-04-23
- First posted
- 2018-10-23
- Last updated
- 2021-05-25
Locations
9 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03716570. Inclusion in this directory is not an endorsement.