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

August 6, 2019 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • Research Site
      • Oviedo, Florida, United States, 32765-4515
        • Research Site
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75247
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99202
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
Single intravenous (IV) low dose infusion with staggered participant dosing
Drug: Placebo
IV infusion
Drug: BIIB054
IV infusion
EXPERIMENTAL: Cohort 2
Single IV ascending dose infusion with staggered participant dosing
Drug: Placebo
IV infusion
Drug: BIIB054
IV infusion
EXPERIMENTAL: Cohort 3
Single IV ascending dose infusion with staggered participant dosing
Drug: Placebo
IV infusion
Drug: BIIB054
IV infusion
EXPERIMENTAL: Cohort 4
Single IV ascending dose infusion with staggered participant dosing
Drug: Placebo
IV infusion
Drug: BIIB054
IV infusion
EXPERIMENTAL: Cohort 5
Single IV ascending dose infusion with staggered participant dosing
Drug: Placebo
IV infusion
Drug: BIIB054
IV infusion
EXPERIMENTAL: Cohort 6
Single IV ascending dose infusion with staggered participant dosing
Drug: Placebo
IV infusion
Drug: BIIB054
IV infusion
EXPERIMENTAL: Cohort 7
Single IV ascending dose infusion with staggered participant dosing
Drug: Placebo
IV infusion
Drug: BIIB054
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 Weeks
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.
20 Weeks
Montreal Cognitive Assessment (MoCA)
Time Frame: 20 Weeks
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
20 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 Weeks
evaluation of anti-BIIB054 antibodies in serum
Time Frame: 20 Weeks
evaluate the immunogenicity of BIIB054 after single-dose administration
20 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

November 20, 2017

Study Completion (ACTUAL)

November 20, 2017

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (ESTIMATE)

June 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 228HV101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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