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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

Sponsor:

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

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.

Locations

  • California Clinical Trials Medical Group (CCTMG), Glendale, California, United States, 91206
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