NCT02459886|CompletedPhase 1FDA Drug

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

Biogen ClinicalTrials.gov

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1 other identifier

228HV101

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2015

StartedJul 2015

CompletionNov 2017

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

May 29, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed

29 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed

Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

2.4 years

First QC Date

May 29, 2015

Last Update Submit

August 6, 2019

Conditions

Parkinson's Disease Healthy

Keywords

alpha synucleinPD

Outcome Measures

Primary Outcomes (3)

Adverse events/serious adverse events (AEs/SAEs),
After a range of single BIIB054 doses administered as a single IV infusion in healthy participants and participants with early Parkinson's Disease, clinical laboratory test data, vital signs, neurological and physical examination findings, 12-lead electrocardiogram (ECG) data, and brain magnetic resonance imaging (MRI) findings will be used in the evaluation of AEs/SAEs.
20 Weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale, or C-SSRS, is a suicidal ideation rating scale created by researchers at Columbia University to evaluate suicidality.
20 Weeks
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
20 Weeks

Secondary Outcomes (2)

Evaluate serum BIIB054 concentrations and PK parameters
20 Weeks
evaluation of anti-BIIB054 antibodies in serum
20 Weeks

Study Arms (7)

Cohort 1

EXPERIMENTAL

Single intravenous (IV) low dose infusion with staggered participant dosing

Drug: BIIB054Drug: Placebo