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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02459886
• Date of registration: 29/05/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
• Scientific 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
• Date of first enrolment: July 1, 2015
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02459886
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: BIIB054

Primary Outcome(s)

Columbia Suicide Severity Rating Scale (C-SSRS) [Time Frame: 20 Weeks]

Adverse events/serious adverse events (AEs/SAEs), [Time Frame: 20 Weeks]

Montreal Cognitive Assessment (MoCA) [Time Frame: 20 Weeks]

Secondary Outcome(s)

evaluation of anti-BIIB054 antibodies in serum [Time Frame: 20 Weeks]

Evaluate serum BIIB054 concentrations and PK parameters [Time Frame: 20 Weeks]

Secondary ID(s)

228HV101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors