Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086602
• Other study ID #: IZD334-001
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2019
• Est. completion date: February 4, 2020

Study information

• Verified date: February 2020
• Source: Inflazome UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cryopyrin Associated Periodic Syndrome
• Cryopyrin-Associated Periodic Syndromes
• Healthy Volunteers
• Syndrome

Intervention

Drug:
• IZD334
Active Drug
• Placebos
Placebo to Match

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Inflazome UK Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events [Safety and Tolerability]	Incidence, frequency and severity of treatment emergent adverse events.	Day 1-8 for SAD
Primary	Incidence of treatment emergent adverse events [Safety and Tolerability]	Incidence, frequency and severity of treatment emergent adverse events.	Day 1-16 for MAD
Primary	Peak plasma concentration (Cmax) single dose	Peak plasma concentration following single dose administration	Day 1-3
Primary	Area under the plasma concentration versus time curve (AUC)- single dose	AUC following single dose administration	Day 1-3
Primary	Peak Plasma Concentration (Cmax)-multiple dose	Peak plasma concentration following multiple dose administration	Days 1-9
Primary	Area under the plasma concentration versus time curve (AUC)- multiple dose	AUC following multiple dose administration	Days 1-9
Secondary	Reduction of IL-1 production in stimulated whole blood	% reduction in IL-1 production in stimulated whole blood as measured by ELISA	Day 1-3 for SAD and Day 1-9 for MAD]
Secondary	Reduction in CAPS symptom scores	Reduction in Physician Assessed CAPS scores based on 8 point questionnaire	Day 1-15