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

NCT ID: NCT03611569

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2021-07-26

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

Conditions

Healthy; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AF82422

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

Group Type: EXPERIMENTAL

Lu AF82422

Intervention Type: DRUG

Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo - concentrate for solution for infusion, single dose

Interventions

Lu AF82422

Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose

Intervention Type: DRUG

Placebo

placebo - concentrate for solution for infusion, single dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

California Clinical Trials Medical Group (CCTMG)

Glendale, California, United States

Reserach Center of America

Hollywood, Florida, United States

PPD

Orlando, Florida, United States

Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

17699A

Identifier Type: -

Identifier Source: org_study_id