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

Biogen66 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson's Disease Healthy

Interventions

BIIB054DRUG

IV infusion

PlaceboDRUG

IV infusion

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (9)

Research Site

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

Research Site

Hallandale, Florida, United States

Research Site

Oviedo, Florida, United States

Research Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 20 Weeks

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.

Time frame: 20 Weeks

Montreal Cognitive Assessment (MoCA)

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

Time frame: 20 Weeks

Secondary Outcomes

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.

Time frame: 20 Weeks

evaluation of anti-BIIB054 antibodies in serum

evaluate the immunogenicity of BIIB054 after single-dose administration

Time frame: 20 Weeks

Data from ClinicalTrials.gov

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