NCT03611569

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

July 26, 2018

Last Update Submit

October 5, 2021

Conditions

HealthyParkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • AUC 0-t

    From dosing to Day 84

  • Cmax

    From dosing to Day 84

  • CL

    From dosing to Day 84

Study Arms (2)

Lu AF82422

EXPERIMENTAL

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

Drug: Lu AF82422

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lu AF82422DRUG

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

Lu AF82422
PlaceboDRUG

placebo - concentrate for solution for infusion, single dose

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

California Clinical Trials Medical Group (CCTMG)

Glendale, California, 91206, United States

Location

Reserach Center of America

Hollywood, Florida, 33024, United States

Location

PPD

Orlando, Florida, 32806, United States

Location

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

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Cohort
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 2, 2018

Study Start

July 25, 2018

Primary Completion

July 26, 2021

Study Completion

July 26, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations

US(4)