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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT03611569
• Date of registration: 26/07/2018
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
• Scientific 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
• Date of first enrolment: July 25, 2018
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03611569
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Parkinson Disease

Intervention(s)

Drug: Placebo

Drug: Lu AF82422

Primary Outcome(s)

Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Time Frame: From dosing to Day 84]

Secondary Outcome(s)

CL [Time Frame: From dosing to Day 84]

AUC 0-t [Time Frame: From dosing to Day 84]

Cmax [Time Frame: From dosing to Day 84]

Secondary ID(s)

17699A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors