Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04086602
• Date of registration: 09/09/2019
• Prospective Registration: Yes
• Primary sponsor: Inflazome UK Ltd
• Public title: Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334
• 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 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
• Date of first enrolment: September 13, 2019
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04086602
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Jason Lickliter, MBBS, PhD
• Affiliation: Nucleus Network

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cryopyrin Associated Periodic Syndrome

Healthy Volunteers

Intervention(s)

Drug: Placebos

Drug: IZD334

Primary Outcome(s)

Incidence of treatment emergent adverse events [Safety and Tolerability] [Time Frame: Day 1-8 for SAD]

Peak plasma concentration (Cmax) single dose [Time Frame: Day 1-3]

Peak Plasma Concentration (Cmax)-multiple dose [Time Frame: Days 1-9]

Incidence of treatment emergent adverse events [Safety and Tolerability] [Time Frame: Day 1-16 for MAD]

Area under the plasma concentration versus time curve (AUC)- multiple dose [Time Frame: Days 1-9]

Area under the plasma concentration versus time curve (AUC)- single dose [Time Frame: Day 1-3]

Secondary Outcome(s)

Reduction in CAPS symptom scores [Time Frame: Day 1-15]

Reduction of IL-1 production in stimulated whole blood [Time Frame: Day 1-3 for SAD and Day 1-9 for MAD]]

Secondary ID(s)

IZD334-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors