Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
Healthy, Parkinson Disease
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion criteria:
Healthy subjects:
- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)
Patients with Parkinson's disease:
- Men and women with a clinical diagnosis of idiopathic Parkinson's disease, Hoehn and Yahn (H&Y, stage 1-3)
- For a minimum of three months prior to enrolment, Parkinson's disease symptoms have been stable and is anticipated to be stable during the study duration as judged by the PI
- If on Parkinson's disease treatment the dose must be stable for a minimum of three months prior to enrolment and is anticipated to be stable during the study duration as judged by the PI
- ≥40 and ≤80 years of age
- BMI ≥18 and ≤35 kg/m2
Exclusion criteria:
- Atypical Parkinsonism
- Clinically relevant structural brain abnormality, as assessed using MRI
- Mild cognitive impairment, measured as a Montreal cognitive assessment (MoCA) score =<21
- Any past or current treatment with an active vaccine targeting alpha-synuclein
- Any past or current treatment with a monoclonal antibody within the last 12 months
Other in- and exclusion criteria may apply.
Sites / Locations
- California Clinical Trials Medical Group (CCTMG)
- Reserach Center of America
- PPD
- Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lu AF82422
Placebo
Part A: Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women) Part B: Cohort B1, B2, B3: 24 patients with Parkinson's disease
Part A: Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women) Part B: Cohort B1, B2, B3: 24 patients with Parkinson's disease