PK Study in Patients With Parkinson's Disease With IZD174

Inflazome

Status and phase

Withdrawn

Phase 1

Conditions

Parkinson Disease

Treatments

Drug: IZD174

Study type

Interventional

Funder types

Industry

Identifiers

NCT04338997

IZD174-003

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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.