Parkinson DiseasePhase 1NCT04338997
PK Study in Patients With Parkinson's Disease With IZD174
A Phase 1 study testing IZD174 in people with Parkinson Disease, run by Inflazome UK Ltd.
Trial summary
Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- IZD174
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's Disease
Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- IZD174
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IZD174Drug
Small molecule inhibitor of NLRP3
| Study group | Role | What they receive |
|---|---|---|
| IZD174 | Experimental | Intra subject dose escalation of IZD174 Receives: Drug: IZD174 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of IZD174 in plasma
Plasma PK profile following an intra-individual dose escalation of IZD174
Measured: Pre-dose to 36 hours post dose
Concentration of IZD174 in cerebrospinal fluid
CSF PK profile following an intra-individual dose escalation of IZD174
Measured: Pre-dose to 36 hours post dose
Ratio of IZD174 concentration in plasma to CSF
CSF to plasma concentration ratio at each time point
Measured: Pre-dose to 36 hours post dose
Secondary outcomes (2)
Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood
Inhibition of IL-1 secretion by ex-vivo stimulated whole blood
Measured: Pre-dose to 36 hours post dose
Incidence of Treatment-Emergent Adverse Events
Safety \& Tolerability as measured by incidence if Treatment-Emergent Adverse events
Measured: Day 0 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study startOct 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Strategic decision by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflazome UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teus van Laar, MD, PhD, Principal investigator, UMCG Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338997
- Sponsor's protocol ID
- IZD174-003
- Status last verified
- Sep 2020
- First submitted
- 3 Apr 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04338997
- Acronym / sponsor ID
- IZD174-003
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic decision by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inflazome UK LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IZD174 | Experimental | Drug: IZD174Intra subject dose escalation of IZD174 |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IZD174Small molecule inhibitor of NLRP3 | Drug | IZD174 |
Primary outcome
Concentration of IZD174 in plasma
Time frame: Pre-dose to 36 hours post dose
Plasma PK profile following an intra-individual dose escalation of IZD174
Concentration of IZD174 in cerebrospinal fluid
Time frame: Pre-dose to 36 hours post dose
CSF PK profile following an intra-individual dose escalation of IZD174
Ratio of IZD174 concentration in plasma to CSF
Time frame: Pre-dose to 36 hours post dose
CSF to plasma concentration ratio at each time point
2 secondary outcomes
Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood
Time frame: Pre-dose to 36 hours post dose
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 0 to Day 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teus van Laar, MD, PhD principal investigator
UMCG Groningen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IZD174 in people with Parkinson Disease, run by Inflazome UK Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of IZD174 in plasma (time frame: Pre-dose to 36 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.