Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy, Parkinson Disease
In brief
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
Key facts
- Study ID
- NCT03611569
- Run by
- H. Lundbeck A/S
- People needed
- 74
- Starts
- 2018-07-25
- Expected to finish
- 2021-07-26
- Last updated by the study team
- 2021-10-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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
- Other in- and exclusion criteria may apply.
Where it is running
- California Clinical Trials Medical Group (CCTMG) — Glendale, California, United States
- Reserach Center of America — Hollywood, Florida, United States
- PPD — Orlando, Florida, United States
- Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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