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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04015076
Registration number
NCT04015076
Ethics application status
Date submitted
8/07/2019
Date registered
10/07/2019
Date last updated
27/03/2020
Titles & IDs
Public title
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
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Scientific title
A Phase 1, Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Inzomelid in Healthy Adult Participants as Well as an Open Label Cohort to Confirm the Safety, Pharmacokinetics, and Pharmacodynamics of Inzomelid in Adult Patients With Cryopyrin-Associated Periodic Syndromes
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Secondary ID [1]
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IZD174-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Inzomelid
Treatment: Drugs - Placebo
Experimental: Single Ascending Dose - Inzomelid or Placebo
Experimental: Multiple Ascending Dose - Inzomelid or Placebo
Experimental: Patients with CAPS - Inzomelid Open Label
Treatment: Drugs: Inzomelid
Active Drug
Treatment: Drugs: Placebo
Placebo to Match
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment emergent advert events [Safety and Tolerability]
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Assessment method [1]
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Incidence, frequency and severity of treatment emergent advert events
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Timepoint [1]
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Day 1-8 for SAD, Day 1-16 for MAD
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Primary outcome [2]
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Peak Plasma Concentration (Cmax)-single dose
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Assessment method [2]
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Peak plasma concentration following single dose administration
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Timepoint [2]
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Day 1-3
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Primary outcome [3]
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Area under the plasma concentration versus time curve (AUC)- single dose
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Assessment method [3]
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AUC following single dose administration
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Timepoint [3]
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Day 1-3
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Primary outcome [4]
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Peak Plasma Concentration (Cmax)-multiple dose
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Assessment method [4]
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Peak plasma concentration following multiple dose administration
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Timepoint [4]
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Days 1-9
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Primary outcome [5]
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Area under the plasma concentration versus time curve (AUC)- multiple dose
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Assessment method [5]
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AUC following multiple dose administration
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Timepoint [5]
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Days 1-9
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Primary outcome [6]
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Peak Plasma Concentration (Cmax)-multiple dose
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Assessment method [6]
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Peak plasma concentration following multiple dose administration
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Timepoint [6]
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Days 1-16
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Primary outcome [7]
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Area under the plasma concentration versus time curve (AUC)- multiple dose
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Assessment method [7]
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AUC following multiple dose administration
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Timepoint [7]
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Days 1-16
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Secondary outcome [1]
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Pharmacodynamic activity
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Assessment method [1]
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NLRP3 Inhibition in whole blood
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Timepoint [1]
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Day 1-3 for SAD and Day 1-9 for MAD
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Secondary outcome [2]
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Reduction in CAPS symptom scores
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Assessment method [2]
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Reduction in Physician Assessed CAPS scores based on 8 point questionnaire
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Timepoint [2]
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Days 1-15
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Eligibility
Key inclusion criteria
Inclusion Criteria- Healthy Volunteers:
- Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of
informed consent);
- Participants must be in good general health, with no significant medical history, have
no clinically significant abnormalities on physical examination at Screening and/or
before administration of the initial dose of study drug;
- Participants must have a Body Mass Index (BMI) between =18.0 and =32.0 kg/m2 at
Screening;
Inclusion Criteria- CAPS Patients:
* Patients with a confirmed diagnosis of CAPS (FCAS, NOMID, or MWS) aged 18 to 70 years
(inclusive at the time of informed consent);
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria- Healthy Volunteers:
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period;
- Prior or ongoing medical conditions, medical history, physical findings, or laboratory
abnormality that, in the Investigator's (or delegate's) opinion, could adversely
affect the safety of the participant;
- Presence of any underlying physical or psychological medical condition that, in the
opinion of the Investigator, would make it unlikely that the participant will comply
with the protocol or complete the study per protocol;
Exclusion Criteria- CAPS Patients:
- Live vaccinations within 3 months prior to Screening, for the duration of the study
and for up to 3 months following the last dose of study drug;
- Positive QuantiFERON test at the Screening visit or within 2 months prior to
Screening.
Participants who have a positive QuantiFERON test with documentation of BCG vaccination,
who are at low environmental risk for TB infection or reactivation, and have a negative
chest X-ray can be included;
* Pregnant or lactating at Screening or planning to becomepregnant (self or partner) at any
time during the study, including the follow-up period;
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/03/2020
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Nucleus Network - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Inflazome UK Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first in human (FIH), single-centre, double blind, randomised, cross-over, SAD
followed by a MAD study of Inzomelid. The study is designed to evaluate the safety,
tolerability, PK, PD, and food effect of Inzomelid in healthy adult participants and to
evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of Inzomelid in
adult patients with CAPS. Oversight will be provided by a safety monitoring committee (SMC)
comprised of the Investigator, the Sponsor's Medical Monitor and an Independent Medical
Monitor.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04015076
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ben Snyder, MB, BS
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Address
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Nucleus Network
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04015076
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