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
Overview
- Phase
- Phase 1
- Intervention
- BIIB054
- Conditions
- Parkinson's Disease
- Sponsor
- Biogen
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Columbia Suicide Severity Rating Scale (C-SSRS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Detailed Description
Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with early PD will be enrolled in Cohort 7
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
Cohort 7
Single IV ascending dose infusion with staggered participant dosing
Intervention: BIIB054
Cohort 1
Single intravenous (IV) low dose infusion with staggered participant dosing
Intervention: BIIB054
Cohort 1
Single intravenous (IV) low dose infusion with staggered participant dosing
Intervention: Placebo
Cohort 2
Single IV ascending dose infusion with staggered participant dosing
Intervention: BIIB054
Cohort 2
Single IV ascending dose infusion with staggered participant dosing
Intervention: Placebo
Cohort 3
Single IV ascending dose infusion with staggered participant dosing
Intervention: BIIB054
Cohort 3
Single IV ascending dose infusion with staggered participant dosing
Intervention: Placebo
Cohort 4
Single IV ascending dose infusion with staggered participant dosing
Intervention: BIIB054
Cohort 4
Single IV ascending dose infusion with staggered participant dosing
Intervention: Placebo
Cohort 5
Single IV ascending dose infusion with staggered participant dosing
Intervention: BIIB054
Cohort 5
Single IV ascending dose infusion with staggered participant dosing
Intervention: Placebo
Cohort 6
Single IV ascending dose infusion with staggered participant dosing
Intervention: BIIB054
Cohort 6
Single IV ascending dose infusion with staggered participant dosing
Intervention: Placebo
Cohort 7
Single IV ascending dose infusion with staggered participant dosing
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Montreal Cognitive Assessment (MoCA)
Time Frame: 20 Weeks
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
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.
Secondary Outcomes
- Evaluate serum BIIB054 concentrations and PK parameters(20 Weeks)
- evaluation of anti-BIIB054 antibodies in serum(20 Weeks)