Healthy VolunteersPhase 1NCT04086602
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334
A Phase 1 study testing IZD334 in people with Healthy Volunteers and Cryopyrin Associated Periodic Syndrome, run by Inflazome UK Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Cryopyrin Associated Periodic Syndrome
- What is being tested?
- IZD334
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Sep 2019to 4 Feb 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Patients with a confirmed diagnosis of CAPS (FCAS or MWS) aged 18 to 65 years (inclusive at the time of informed consent)
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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 IZD334 in Healthy Adult Participants as Well as an Open-label Cohort to Confirm the Safety, Pharmacokinetics, and Pharmacodynamics in Adult Patients With Cryopyrin-Associated Periodic Syndromes
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.
- Being tested
- IZD334, Placebos
- Medical subject headings
- Cryopyrin-Associated Periodic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IZD334Drug
Active Drug
PlacebosDrug
Placebo to Match
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Once daily oral IZD334 or Placebo Receives: Drug: IZD334; Drug: Placebos |
| Multiple Ascending Dose | Experimental | Once or twice daily oral IZD334 or Placebo Receives: Drug: IZD334; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Measured: Day 1-8 for SAD
Incidence of treatment emergent adverse events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Measured: Day 1-16 for MAD
Peak plasma concentration (Cmax) single dose
Peak plasma concentration following single dose administration
Measured: Day 1-3
Area under the plasma concentration versus time curve (AUC)- single dose
AUC following single dose administration
Measured: Day 1-3
Peak Plasma Concentration (Cmax)-multiple dose
Peak plasma concentration following multiple dose administration
Measured: Days 1-9
Area under the plasma concentration versus time curve (AUC)- multiple dose
AUC following multiple dose administration
Measured: Days 1-9
Secondary outcomes (2)
Reduction of IL-1 production in stimulated whole blood
% reduction in IL-1 production in stimulated whole blood as measured by ELISA
Measured: 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
Measured: Day 1-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start13 Sep 2019
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflazome UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, MBBS, PhD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086602
- Sponsor's protocol ID
- IZD334-001
- Status last verified
- Feb 2020
- First submitted
- 9 Sep 2019
- Last updated
- 2 Mar 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 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 IZD334 in Healthy Adult Participants as Well as an Open-label Cohort to Confirm the Safety, Pharmacokinetics, and Pharmacodynamics in Adult Patients With Cryopyrin-Associated Periodic Syndromes
- ClinicalTrials.gov ID
- NCT04086602
- Acronym / sponsor ID
- IZD334-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Inflazome UK LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 11 Sep 2019 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: IZD334, Drug: PlacebosOnce daily oral IZD334 or Placebo |
| Multiple Ascending Dose | Experimental | Drug: IZD334, Drug: PlacebosOnce or twice daily oral IZD334 or Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Patients with a confirmed diagnosis of CAPS (FCAS or MWS) aged 18 to 65 years (inclusive at the time of informed consent)
Key exclusion criteria (6 listed)
- 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
- 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;
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 |
|---|---|---|
| IZD334Active Drug | Drug | Multiple Ascending Dose, Single Ascending Dose |
| PlacebosPlacebo to Match | Drug | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
Incidence of treatment emergent adverse events [Safety and Tolerability]
Time frame: Day 1-8 for SAD
Incidence, frequency and severity of treatment emergent adverse events.
Incidence of treatment emergent adverse events [Safety and Tolerability]
Time frame: Day 1-16 for MAD
Incidence, frequency and severity of treatment emergent adverse events.
Peak plasma concentration (Cmax) single dose
Time frame: Day 1-3
Peak plasma concentration following single dose administration
Area under the plasma concentration versus time curve (AUC)- single dose
Time frame: Day 1-3
AUC following single dose administration
Peak Plasma Concentration (Cmax)-multiple dose
Time frame: Days 1-9
Peak plasma concentration following multiple dose administration
Area under the plasma concentration versus time curve (AUC)- multiple dose
Time frame: Days 1-9
AUC following multiple dose administration
2 secondary outcomes
Reduction of IL-1 production in stimulated whole blood
Time frame: Day 1-3 for SAD and Day 1-9 for MAD]
Reduction in CAPS symptom scores
Time frame: Day 1-15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
Jason Lickliter, MBBS, PhD principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IZD334 in people with Healthy Volunteers and Cryopyrin Associated Periodic Syndrome, run by Inflazome UK Ltd at 1 site in Australia.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment emergent adverse events [Safety and Tolerability] (time frame: Day 1-8 for SAD). The study lists 6 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 2 Mar 2020.