Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 Single intravenous (IV) low dose infusion with staggered participant dosing |
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
|
| Experimental: Cohort 2 Single IV ascending dose infusion with staggered participant dosing |
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
|
| Experimental: Cohort 3 Single IV ascending dose infusion with staggered participant dosing |
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
|
| Experimental: Cohort 4 Single IV ascending dose infusion with staggered participant dosing |
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
|
| Experimental: Cohort 5 Single IV ascending dose infusion with staggered participant dosing |
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
|
| Experimental: Cohort 6 Single IV ascending dose infusion with staggered participant dosing |
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
|
| Experimental: Cohort 7 Single IV ascending dose infusion with staggered participant dosing |
Drug: BIIB054
IV infusion
Drug: Placebo
IV infusion
|
Outcome Measures
Primary Outcome Measures
- Adverse events/serious adverse events (AEs/SAEs), [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) [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) [20 Weeks]
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
Secondary Outcome Measures
- Evaluate serum BIIB054 concentrations and PK parameters [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 [20 Weeks]
evaluate the immunogenicity of BIIB054 after single-dose administration
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Washington | District of Columbia | United States | 20007 |
| 2 | Research Site | Hallandale Beach | Florida | United States | 33009 |
| 3 | Research Site | Oviedo | Florida | United States | 32765-4515 |
| 4 | Research Site | Evansville | Indiana | United States | 47710 |
| 5 | Research Site | Farmington Hills | Michigan | United States | 48334 |
| 6 | Research Site | Durham | North Carolina | United States | 27705 |
| 7 | Research Site | Cleveland | Ohio | United States | 44195 |
| 8 | Research Site | Dallas | Texas | United States | 75247 |
| 9 | Research Site | Spokane | Washington | United States | 99202 |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 228HV101