Status:
WITHDRAWN
PK Study in Patients With Parkinson's Disease With IZD174
Lead Sponsor:
Inflazome UK Ltd
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-75 years
Phase:
PHASE1
Brief Summary
Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease
Detailed Description
After assessing eligibility during a screening period of up to 4 weeks, up to 6 subjects will be included. Subjects will check into the clinic one day prior to dosing (Day -1). To evaluate and compar...
Eligibility Criteria
Inclusion
- The subject is a man or woman aged between 45 and 75, 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 wit 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.
- The subject understands the nature and purpose of the study, including possible risks and side effects, and i willing and able to comply with all compulsory stud procedures and provides signed and dated written informed consent (in accordance with local regulations) prior to any study procedures being performed.
Exclusion
- 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.
- The subject has any severe, progressive or uncontrolled medical condition at Screening or on Day -1 that in the judgment of the investigator prevents the subject from participating in the study.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04338997
Start Date
October 1 2020
End Date
December 1 2020
Last Update
December 4 2020
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