Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
Parkinson's Disease, Healthy
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring alpha synuclein, PD
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Cohort 7
Single intravenous (IV) low dose infusion with staggered participant dosing
Single IV ascending dose infusion with staggered participant dosing
Single IV ascending dose infusion with staggered participant dosing
Single IV ascending dose infusion with staggered participant dosing
Single IV ascending dose infusion with staggered participant dosing
Single IV ascending dose infusion with staggered participant dosing
Single IV ascending dose infusion with staggered participant dosing