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

Primary Purpose

Parkinson's Disease, Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BIIB054
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring alpha synuclein, PD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Arm Description

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

Single IV ascending dose infusion with staggered participant dosing

Single IV ascending dose infusion with staggered participant dosing

Single IV ascending dose infusion with staggered participant dosing

Single IV ascending dose infusion with staggered participant dosing

Single IV ascending dose infusion with staggered participant dosing

Single IV ascending dose infusion with staggered participant dosing

Outcomes

Primary Outcome Measures

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.
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.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.

Secondary Outcome Measures

Evaluate serum BIIB054 concentrations and PK parameters
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (0-∞), AUC from time 0 to time of the last measurable concentration (AUC0-tlast), maximum concentration (Cmax), time to Cmax (Tmax), elimination half-life (t1/2), and clearance (Cl), will be used to assess the serum PK profile of BIIB054 after single-dose administration.
evaluation of anti-BIIB054 antibodies in serum
evaluate the immunogenicity of BIIB054 after single-dose administration

Full Information

First Posted
May 29, 2015
Last Updated
August 6, 2019
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02459886
Brief Title
Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Healthy
Keywords
alpha synuclein, PD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Single intravenous (IV) low dose infusion with staggered participant dosing
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Single IV ascending dose infusion with staggered participant dosing
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Single IV ascending dose infusion with staggered participant dosing
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Single IV ascending dose infusion with staggered participant dosing
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Single IV ascending dose infusion with staggered participant dosing
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
Single IV ascending dose infusion with staggered participant dosing
Arm Title
Cohort 7
Arm Type
Experimental
Arm Description
Single IV ascending dose infusion with staggered participant dosing
Intervention Type
Drug
Intervention Name(s)
BIIB054
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Adverse events/serious adverse events (AEs/SAEs),
Description
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.
Time Frame
20 Weeks
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The Columbia Suicide Severity Rating Scale, or C-SSRS, is a suicidal ideation rating scale created by researchers at Columbia University to evaluate suicidality.
Time Frame
20 Weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
Time Frame
20 Weeks
Secondary Outcome Measure Information:
Title
Evaluate serum BIIB054 concentrations and PK parameters
Description
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (0-∞), AUC from time 0 to time of the last measurable concentration (AUC0-tlast), maximum concentration (Cmax), time to Cmax (Tmax), elimination half-life (t1/2), and clearance (Cl), will be used to assess the serum PK profile of BIIB054 after single-dose administration.
Time Frame
20 Weeks
Title
evaluation of anti-BIIB054 antibodies in serum
Description
evaluate the immunogenicity of BIIB054 after single-dose administration
Time Frame
20 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: 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. Must have a body mass index from 19 to 32 kg/m2, inclusive. Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG. For cohort 7 only: Diagnosis of idiopathic PD Key Exclusion Criteria: History of cardiovascular disease. Subject smokes more than 5 cigarettes or the equivalent in tobacco daily. Surgery within 3 months prior to Day -1 (other than minor cosmetic surgery and minor dental surgery, as determined by the Investigator). History or positive test result for hepatitis C, hepatitis B, or human immunodeficiency virus (HIV). Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Research Site
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765-4515
Country
United States
Facility Name
Research Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

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

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