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Completed

NCT Number: NCT02459886

Single-Ascending Dose Study of BIIB054 in Healthy Participants and 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Healthy Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson Disease 4, Autosomal Dominant Lewy Body Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Washington D.C., District of Columbia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB054

Drug

IV infusion

Placebo

Drug

IV infusion

Primary outcomes

  1. 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.

  2. 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.

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: 20 Weeks

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

Secondary outcomes

  1. 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.

  2. evaluation of anti-BIIB054 antibodies in serum

    Time frame: 20 Weeks

    evaluate the immunogenicity of BIIB054 after single-dose administration

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2015
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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