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Completed

NCT Number: NCT03611569

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

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

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Key information

Conditions

Healthy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AF82422

Drug

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

Placebo

Drug

placebo - concentrate for solution for infusion, single dose

Primary outcomes

  1. Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: 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 outcomes

  1. AUC 0-t

    Time frame: From dosing to Day 84

    Area under the Lu AF82422 plasma concentration curve from zero to time t

  2. Cmax

    Time frame: From dosing to Day 84

    Maximum observed plasma concentration of Lu AF82422

  3. CL

    Time frame: From dosing to Day 84

    Clearance of Lu AF82422

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2018
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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