HealthyPhase 1NCT04015076

Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

A Phase 1 study testing Inzomelid in people with Healthy, run by Inflazome UK Ltd at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Inzomelid
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteAustralia
Study dates: 16 Jul 2019to 23 Mar 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 70 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;
Patients with a confirmed diagnosis of CAPS (FCAS, NOMID, or MWS) aged 18 to 70 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;
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;

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Network
Melbourne, Queensland

Other trials in Australia

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 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

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.

Conditions: Healthy
Being tested: Inzomelid, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InzomelidDrug
Active Drug
PlaceboDrug
Placebo to Match

Study groups in NCT04015076
Study group	Role	What they receive
Single Ascending Dose	Experimental	Inzomelid or Placebo Receives: Drug: Inzomelid; Drug: Placebo
Multiple Ascending Dose	Experimental	Inzomelid or Placebo Receives: Drug: Inzomelid; Drug: Placebo
Patients with CAPS	Experimental	Inzomelid Open Label Receives: Drug: Inzomelid

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Pharmacodynamic activity
NLRP3 Inhibition in whole blood
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: Days 1-15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 201923 Mar 2020

First posted10 Jul 2019
Study start16 Jul 2019
Primary completion23 Mar 2020
Study completion23 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04015076
Sponsor's protocol ID: IZD174-001
Status last verified: Feb 2020
First submitted: 8 Jul 2019
Last updated: 27 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 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 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
ClinicalTrials.gov ID: NCT04015076
Acronym / sponsor ID: IZD174-001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Inflazome UK LtdIndustry (pharma, biotech, devices)
Study start: 16 Jul 2019 (actual)
Primary completion: 23 Mar 2020 (actual)
Study completion: 23 Mar 2020 (actual)
First posted: 10 Jul 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Single Ascending Dose	Experimental	Drug: Inzomelid, Drug: PlaceboInzomelid or Placebo
Multiple Ascending Dose	Experimental	Drug: Inzomelid, Drug: PlaceboInzomelid or Placebo
Patients with CAPS	Experimental	Drug: InzomelidInzomelid Open Label

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 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;
Patients with a confirmed diagnosis of CAPS (FCAS, NOMID, or MWS) aged 18 to 70 years (inclusive at the time of informed consent);

Key exclusion criteria (7 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;
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.

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
InzomelidActive Drug	Drug	Multiple Ascending Dose, Patients with CAPS, Single Ascending Dose
PlaceboPlacebo to Match	Drug	Multiple Ascending Dose, Single Ascending Dose

Primary outcome

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

2 secondary outcomes

Pharmacodynamic activity
Time frame: Day 1-3 for SAD and Day 1-9 for MAD
Reduction in CAPS symptom scores
Time frame: Days 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 27 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.

Ben Snyder, MB, BS 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 Inzomelid in people with Healthy, 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 4 inclusion and 7 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 27 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 advert events [Safety and Tolerability] (time frame: Day 1-8 for SAD, Day 1-16 for MAD). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04015076.

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 27 Mar 2020.