Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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

Official Title
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Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease

Conditions
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Healthy, Parkinson Disease

Intervention / Treatment
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* Drug: Lu AF82422
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Cohort
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF82422<br>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 | Drug: Lu AF82422<br>* Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose<br>|
| Placebo Comparator: Placebo<br>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 | Drug: Placebo<br>* placebo - concentrate for solution for infusion, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters) | From dosing to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-t | Area under the Lu AF82422 plasma concentration curve from zero to time t | From dosing to Day 84 | 
| Cmax | Maximum observed plasma concentration of Lu AF82422 | From dosing to Day 84 | 
| CL | Clearance of Lu AF82422 | From dosing to Day 84 |