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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy; Parkinson's Disease

Treatments: Drug: BIIB054; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02459886

228HV101

Details and patient eligibility

About

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.

Full description

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

Enrollment: 66 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 7 patient groups

Cohort 1

Experimental group

Description:

Single intravenous (IV) low dose infusion with staggered participant dosing

Treatment:

Drug: Placebo

Drug: BIIB054

Cohort 2

Experimental group

Description:

Single IV ascending dose infusion with staggered participant dosing

Treatment:

Drug: Placebo

Drug: BIIB054

Cohort 3

Experimental group

Description:

Single IV ascending dose infusion with staggered participant dosing

Treatment:

Drug: Placebo

Drug: BIIB054

Cohort 4

Experimental group

Description:

Single IV ascending dose infusion with staggered participant dosing

Treatment:

Drug: Placebo

Drug: BIIB054

Cohort 5

Experimental group

Description:

Single IV ascending dose infusion with staggered participant dosing

Treatment:

Drug: Placebo

Drug: BIIB054

Cohort 6

Experimental group

Description:

Single IV ascending dose infusion with staggered participant dosing

Treatment:

Drug: Placebo

Drug: BIIB054

Cohort 7

Experimental group

Description:

Single IV ascending dose infusion with staggered participant dosing

Treatment:

Drug: Placebo

Drug: BIIB054