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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02459886
First received: May 29, 2015
Last updated: April 26, 2017
Last verified: April 2017
  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.

Condition Intervention Phase
Parkinson's Disease
Healthy
Drug: BIIB054
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Adverse events/serious adverse events (AEs/SAEs), [ Time Frame: 20 Weeks ]
    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) [ Time Frame: 20 Weeks ]
    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) [ Time Frame: 20 Weeks ]
    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 [ Time Frame: 20 Weeks ]
    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 [ Time Frame: 20 Weeks ]
    evaluate the immunogenicity of BIIB054 after single-dose administration


Estimated Enrollment: 66
Actual Study Start Date: July 1, 2015
Estimated Study Completion Date: September 7, 2017
Estimated Primary Completion Date: September 7, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Single intravenous (IV) low dose infusion with staggered participant dosing
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
Experimental: Cohort 2
Single IV ascending dose infusion with staggered participant dosing
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
Experimental: Cohort 3
Single IV ascending dose infusion with staggered participant dosing
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
Experimental: Cohort 4
Single IV ascending dose infusion with staggered participant dosing
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
Experimental: Cohort 5
Single IV ascending dose infusion with staggered participant dosing
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
Experimental: Cohort 6
Single IV ascending dose infusion with staggered participant dosing
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
Experimental: Cohort 7
Single IV ascending dose infusion with staggered participant dosing
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion

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

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02459886

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
United States, California
Research Site Recruiting
San Diego, California, United States, 92037
United States, District of Columbia
Research Site Not yet recruiting
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Research Site Recruiting
Hallandale Beach, Florida, United States, 33009
Research Site Recruiting
Oviedo, Florida, United States, 32765-4515
United States, Georgia
Research Site Not yet recruiting
Atlanta, Georgia, United States, 30331
United States, Indiana
Research Site Active, not recruiting
Evansville, Indiana, United States, 47710
United States, Michigan
Research Site Recruiting
Farmington Hills, Michigan, United States, 48334
United States, North Carolina
Research Site Not yet recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
Research Site Active, not recruiting
Dallas, Texas, United States, 75247
United States, Washington
Research Site Recruiting
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02459886     History of Changes
Other Study ID Numbers: 228HV101
Study First Received: May 29, 2015
Last Updated: April 26, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biogen:
alpha synuclein
PD

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 23, 2017