Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459886
• Other study ID #: 228HV101
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2015
• Est. completion date: November 20, 2017

Study information

• Verified date: August 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with early PD will be enrolled in Cohort 7

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• BIIB054
IV infusion
• Placebo
IV infusion

Locations

Country	Name	City	State
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Durham	North Carolina
United States	Research Site	Evansville	Indiana
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Hallandale Beach	Florida
United States	Research Site	Oviedo	Florida
United States	Research Site	Spokane	Washington
United States	Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.	20 Weeks
Secondary	Evaluate serum BIIB054 concentrations and PK parameters	Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (0-8), 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.	20 Weeks
Secondary	evaluation of anti-BIIB054 antibodies in serum	evaluate the immunogenicity of BIIB054 after single-dose administration	20 Weeks

External Links

•   Link to a publication of summary results for 228HV101.