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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy; Parkinson Disease

Treatments: Drug: Lu AF82422; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03611569

17699A

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Lu AF82422

Experimental group

Description:

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

Treatment:

Drug: Lu AF82422

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo