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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single intravenous (IV) low dose infusion with staggered participant dosing |
|
| Cohort 2 | Experimental | Single IV ascending dose infusion with staggered participant dosing |
|
| Cohort 3 | Experimental | Single IV ascending dose infusion with staggered participant dosing |
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| Cohort 4 | Experimental | Single IV ascending dose infusion with staggered participant dosing |
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| Cohort 5 | Experimental | Single IV ascending dose infusion with staggered participant dosing |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB054 | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 20 Weeks |
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment. | 20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Washington D.C. | District of Columbia | 20007 | United States | ||
| Research Site |
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Single IV ascending dose infusion with staggered participant dosing
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| Cohort 7 | Experimental | Single IV ascending dose infusion with staggered participant dosing |
|
| Placebo | Drug | IV infusion |
|
| 20 Weeks |
| evaluation of anti-BIIB054 antibodies in serum | evaluate the immunogenicity of BIIB054 after single-dose administration | 20 Weeks |
| Hallandale |
| Florida |
| 33009 |
| United States |
| Research Site | Oviedo | Florida | 32765-4515 | United States |
| Research Site | Evansville | Indiana | 47710 | United States |
| Research Site | Farmington Hills | Michigan | 48334 | United States |
| Research Site | Durham | North Carolina | 27705 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Dallas | Texas | 75247 | United States |
| Research Site | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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