Clinical trial NCT02459886: Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Healthy
Keywords: alpha synuclein
PD
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events/serious adverse events (AEs/SAEs),
timeFrame: 20 Weeks
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 20 Weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 20 Weeks
Secondary outcomes:
measure: Evaluate serum BIIB054 concentrations and PK parameters
timeFrame: 20 Weeks
measure: evaluation of anti-BIIB054 antibodies in serum
timeFrame: 20 Weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Hallandale Beach
country: United States
facility: Research Site
state: Florida
city: Oviedo
country: United States
facility: Research Site
state: Florida
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Spokane
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: