PK Study in Patients With Parkinson's Disease With IZD174

Phase 1

Withdrawn

• Conditions: Parkinson Disease
• Interventions: Drug: IZD174

• Registration Number: NCT04338997
• Lead Sponsor: Inflazome UK Ltd

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 compare drug exposure levels in plasma and CSF, plasma and CSF will be serially sampled over a period of 36 hours. Subjects will be discharged from the clinic on Day 5 after all required study procedures are completed and if medically justified.

Subjects will return to the clinic approximately 1 week after discharge from the clinic for a follow-up visit.

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-08
• Status Verified: 2020-09
• Study Start: 2020-10
• Primary Completion: 2020-11
• Study Completion: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IZD174	IZD174	Intra subject dose escalation of IZD174

Primary Outcome Measures

Name	Time	Method
Concentration of IZD174 in plasma	Pre-dose to 36 hours post dose	Plasma PK profile following an intra-individual dose escalation of IZD174
Ratio of IZD174 concentration in plasma to CSF	Pre-dose to 36 hours post dose	CSF to plasma concentration ratio at each time point
Concentration of IZD174 in cerebrospinal fluid	Pre-dose to 36 hours post dose	CSF PK profile following an intra-individual dose escalation of IZD174

Secondary Outcome Measures

Name	Time	Method
Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood	Pre-dose to 36 hours post dose	Inhibition of IL-1 secretion by ex-vivo stimulated whole blood
Incidence of Treatment-Emergent Adverse Events	Day 0 to Day 10	Safety \& Tolerability as measured by incidence if Treatment-Emergent Adverse events