PK Study in Patients With Parkinson's Disease With IZD174

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inflazome UK Ltd

Criteria

Inclusion Criteria:

• 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 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.

• 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.