Healthy, Parkinson Disease
Conditions
Brief summary
The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease
Interventions
DRUGLu AF82422
Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
DRUGPlacebo
placebo - concentrate for solution for infusion, single dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | From dosing to Day 84 | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC 0-t | From dosing to Day 84 | Area under the Lu AF82422 plasma concentration curve from zero to time t |
| Cmax | From dosing to Day 84 | Maximum observed plasma concentration of Lu AF82422 |
| CL | From dosing to Day 84 | Clearance of Lu AF82422 |
Countries
United States
Outcome results
None listed