Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

NCT ID: NCT04086602

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-13
• Study Completion Date: 2020-02-04

Brief 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

Healthy Volunteers; Cryopyrin Associated Periodic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Single Ascending Dose

Once daily oral IZD334 or Placebo

Group Type: EXPERIMENTAL

IZD334

Intervention Type: DRUG

Active Drug

Placebos

Intervention Type: DRUG

Placebo to Match

Multiple Ascending Dose

Once or twice daily oral IZD334 or Placebo

Group Type: EXPERIMENTAL

IZD334

Intervention Type: DRUG

Active Drug

Placebos

Intervention Type: DRUG

Placebo to Match

Interventions

IZD334

Active Drug

Intervention Type: DRUG

Placebos

Placebo to Match

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inflazome UK Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Lickliter, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

IZD334-001

Identifier Type: -

Identifier Source: org_study_id