PK Study in Patients With Parkinson's Disease With IZD174

NCT04338997 | Withdrawn Phase 1

• 1 other identifier: IZD174-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Concentration of IZD174 in plasma

  Plasma PK profile following an intra-individual dose escalation of IZD174

  Pre-dose to 36 hours post dose

• Concentration of IZD174 in cerebrospinal fluid

  CSF PK profile following an intra-individual dose escalation of IZD174

  Pre-dose to 36 hours post dose

• Ratio of IZD174 concentration in plasma to CSF

  CSF to plasma concentration ratio at each time point

  Pre-dose to 36 hours post dose

Secondary Outcomes (2)

• Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood

  Pre-dose to 36 hours post dose

• Incidence of Treatment-Emergent Adverse Events

  Day 0 to Day 10

Study Arms (1)

IZD174

EXPERIMENTAL

Intra subject dose escalation of IZD174

Drug: IZD174

Interventions

IZD174 DRUG

Small molecule inhibitor of NLRP3

IZD174

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inflazome UK Ltd: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Teus van Laar, MD, PhD

  UMCG Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: October 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share