CompletedNCT04086602Updated Mar 2, 2020

Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

A Phase 1 interventional study of IZD334 and Placebos in Healthy Volunteers and Cryopyrin Associated Periodic Syndrome, sponsored by Inflazome UK Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-02.

Sponsored by Inflazome UK Ltd · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in adult patients with CAPS. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of IZD334 in healthy adult participants, and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of IZD334 in adult patients with CAPS.

Conditions studied

Healthy Volunteers
Cryopyrin Associated Periodic Syndrome

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Cryopyrin-Associated Periodic Syndromes 35

In context

Cryopyrin-Associated Periodic Syndromes

35 studies on the registry are indexed under Cryopyrin-Associated Periodic Syndromes; 5 are open to participants now.

This study's enrollment of 64 is above the median of 25 across 26 interventional studies indexed under Cryopyrin-Associated Periodic Syndromes.

Browse Cryopyrin-Associated Periodic Syndromes studies →

Lead sponsor

Inflazome UK Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility 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
Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate

Inclusion Criteria: (CAPS Patients)

*Patients with a confirmed diagnosis of CAPS (FCAS or MWS) aged 18 to 65 years (inclusive at the time of informed consent)

Exclusion Criteria: (Healthy volunteer)

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
Blood donation or significant blood loss within 60 days prior to the first study drug administration

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 64 participants (actual)

Study arms

Experimental
Single Ascending Dose
Once daily oral IZD334 or Placebo
Drug: IZD334 · Drug: Placebos
Experimental
Multiple Ascending Dose
Once or twice daily oral IZD334 or Placebo
Drug: IZD334 · Drug: Placebos

Interventions

DrugIZD334
Active Drug
DrugPlacebos
Placebo to Match

What researchers measure

Primary outcomes

Incidence of treatment emergent adverse events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Time frame: Day 1-8 for SAD
Incidence of treatment emergent adverse events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Time frame: Day 1-16 for MAD
Peak plasma concentration (Cmax) single dose
Peak plasma concentration following single dose administration
Time frame: Day 1-3
Area under the plasma concentration versus time curve (AUC)- single dose
AUC following single dose administration
Time frame: Day 1-3
Peak Plasma Concentration (Cmax)-multiple dose
Peak plasma concentration following multiple dose administration
Time frame: Days 1-9
Area under the plasma concentration versus time curve (AUC)- multiple dose
AUC following multiple dose administration
Time frame: Days 1-9

Secondary outcomes

Reduction of IL-1 production in stimulated whole blood
% reduction in IL-1 production in stimulated whole blood as measured by ELISA
Time frame: Day 1-3 for SAD and Day 1-9 for MAD]
Reduction in CAPS symptom scores
Reduction in Physician Assessed CAPS scores based on 8 point questionnaire
Time frame: Day 1-15

Study locations

1 site

Nucleus Network
Melbourne, Victoria, Australia

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Feb 2020, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 9, 2019
First posted: Sep 11, 2019
StartActual: Sep 13, 2019
Primary completionActual: Feb 4, 2020
CompletionActual: Feb 4, 2020
Last update: Mar 2, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04086602
Lead sponsor: Inflazome UK Ltd
Responsible party: Sponsor
First posted: Sep 11, 2019
Start date: Sep 13, 2019
Primary completion: Feb 4, 2020
Completion: Feb 4, 2020
Last update: Mar 2, 2020

Study contacts

Jason Lickliter, MBBS, PhD

principal investigator · Nucleus Network

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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