NL-OMON49465
Completed
Not Applicable
An open-label Phase 1b study to evaluate the pharmacokinetics and pharmacodynamics in plasma and cerebrospinal fluid (CSF), safety and tolerability of oral IZD174 in patients with Parkinson*s Disease. - CS0339 Inflazome
Inflazome Limited0 sites6 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Inflazome Limited
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject is a man or woman aged between 45 and 69, inclusive.
- •Documented clinically established diagnosis of Parkinson\*s Disease, Hoehn \&
- •Yahr stage 1 to 3 and Montreal Cognitive Assessment greater or equal than 26\.
- •Diagnosis of Parkinson\*s Disease consistent with MDS Research Criteria for the
- •Diagnosis of Parkinson\*s Disease must include bradykinesia with sequence
- •effect, and motor asymmetry (especially if no rest tremor). Diagnosis has to be
- •made less than 3 years prior to Screening.
- •Patients that receive treatment for Parkinson\*s Disease should be on a stable
- •dose level and regimen for at least 14 days prior to study drug administration
- •and should have the intention to stay on this regimen throughout the study.
Exclusion Criteria
- •The subject used any NSAIDs, steroids, colchicine or anti\-IL\-1 inhibitors
- •within 7 days prior to Day 1\.
- •The subject received any investigational drugs within 4 weeks or 5 half\-lives
- •(whichever is longer), prior to Day 1\.
- •The subject had an active systemic infection (other than common cold) within 2
- •weeks prior to Day 1\.
- •The subject has a history of severe hypersensitivity to previous drugs.
Outcomes
Primary Outcomes
Not specified
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