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

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ClinicalTrials.gov Identifier: NCT02459886
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 2, 2015
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE July 1, 2015
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2015)
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, 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2015)
  • 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.
  • measurement of total alpha-synuclein in CSF [ Time Frame: 20 Weeks ]
    to assess engagement of BIIB054 with its molecular target, alpha-synuclein, as reflected by levels of total alpha-synuclein in CSF.
  • evaluation of anti-BIIB054 antibodies in serum [ Time Frame: 20 Weeks ]
    evaluate the immunogenicity of BIIB054 after single-dose administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Healthy
Intervention  ICMJE
  • Drug: BIIB054
    IV infusion
  • Drug: Placebo
    IV infusion
Study Arms  ICMJE
  • Experimental: Cohort 1
    Single intravenous (IV) low dose infusion with staggered participant dosing
    Interventions:
    • Drug: BIIB054
    • Drug: Placebo
  • Experimental: Cohort 2
    Single IV ascending dose infusion with staggered participant dosing
    Interventions:
    • Drug: BIIB054
    • Drug: Placebo
  • Experimental: Cohort 3
    Single IV ascending dose infusion with staggered participant dosing
    Interventions:
    • Drug: BIIB054
    • Drug: Placebo
  • Experimental: Cohort 4
    Single IV ascending dose infusion with staggered participant dosing
    Interventions:
    • Drug: BIIB054
    • Drug: Placebo
  • Experimental: Cohort 5
    Single IV ascending dose infusion with staggered participant dosing
    Interventions:
    • Drug: BIIB054
    • Drug: Placebo
  • Experimental: Cohort 6
    Single IV ascending dose infusion with staggered participant dosing
    Interventions:
    • Drug: BIIB054
    • Drug: Placebo
  • Experimental: Cohort 7
    Single IV ascending dose infusion with staggered participant dosing
    Interventions:
    • Drug: BIIB054
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2016)
66
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2015)
40
Actual Study Completion Date  ICMJE November 20, 2017
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02459886
Other Study ID Numbers  ICMJE 228HV101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP