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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611569
• Other study ID #: 17699A
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2018
• Est. completion date: July 26, 2021

Study information

• Verified date: October 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Parkinson Disease

Intervention

Drug:
• Lu AF82422
Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
• Placebo
placebo - concentrate for solution for infusion, single dose

Locations

Country	Name	City	State
United States	Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital	Baltimore	Maryland
United States	California Clinical Trials Medical Group (CCTMG)	Glendale	California
United States	Reserach Center of America	Hollywood	Florida
United States	PPD	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)	From dosing to Day 84
Secondary	AUC 0-t	Area under the Lu AF82422 plasma concentration curve from zero to time t	From dosing to Day 84
Secondary	Cmax	Maximum observed plasma concentration of Lu AF82422	From dosing to Day 84
Secondary	CL	Clearance of Lu AF82422	From dosing to Day 84