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

Primary Purpose

Healthy, Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lu AF82422
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • California Clinical Trials Medical Group (CCTMG)
  • Reserach Center of America
  • PPD
  • Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lu AF82422

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

AUC 0-t
Area under the Lu AF82422 plasma concentration curve from zero to time t
Cmax
Maximum observed plasma concentration of Lu AF82422
CL
Clearance of Lu AF82422

Full Information

First Posted
July 26, 2018
Last Updated
October 5, 2021
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03611569
Brief Title
Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Cohort
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lu AF82422
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lu AF82422
Intervention Description
Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo - concentrate for solution for infusion, single dose
Primary Outcome Measure Information:
Title
Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
Time Frame
From dosing to Day 84
Secondary Outcome Measure Information:
Title
AUC 0-t
Description
Area under the Lu AF82422 plasma concentration curve from zero to time t
Time Frame
From dosing to Day 84
Title
Cmax
Description
Maximum observed plasma concentration of Lu AF82422
Time Frame
From dosing to Day 84
Title
CL
Description
Clearance of Lu AF82422
Time Frame
From dosing to Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Other in- and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
California Clinical Trials Medical Group (CCTMG)
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Reserach Center of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
PPD
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States

12. IPD Sharing Statement

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

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