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Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

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ClinicalTrials.gov Identifier: NCT04086602
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Inflazome UK Ltd

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Cryopyrin Associated Periodic Syndrome Drug: IZD334 Drug: Placebos Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Healthy volunteer section is double blind. CAPS cohort is open label.
Primary Purpose: Other
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
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
Experimental: Single Ascending Dose
Once daily oral IZD334 or Placebo
Drug: IZD334
Active Drug

Drug: Placebos
Placebo to Match

Experimental: Multiple Ascending Dose
Once or twice daily oral IZD334 or Placebo
Drug: IZD334
Active Drug

Drug: Placebos
Placebo to Match

Experimental: CAPS Patients
Twice daily oral IZD334
Drug: IZD334
Active Drug




Primary Outcome Measures :
  1. 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.

  2. 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.

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

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

  5. Peak Plasma Concentration (Cmax)-multiple dose [ Time Frame: Days 1-9 ]
    Peak plasma concentration following multiple dose administration

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


Secondary Outcome Measures :
  1. Reduction of IL-1 production in stimulated whole blood [ Time Frame: Day 1-3 for SAD and Day 1-9 for MAD] ]
    % reduction in IL-1 production in stimulated whole blood as measured by ELISA

  2. Reduction in CAPS symptom scores [ Time Frame: Day 1-15 ]
    Reduction in Physician Assessed CAPS scores based on 8 point questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086602


Contacts
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Contact: Jeff Thompson, PhD, MBA +44(0)1223 751549 j.thompson@inflazome.com
Contact: Thomas Jung, MD, PhD +44(0)1223 751549 t.jung@inflazome.com

Locations
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Australia, Victoria
Nucleus Network Recruiting
Melbourne, Victoria, Australia
Contact: Jason Lickliter, MBBS, PhD         
Sponsors and Collaborators
Inflazome UK Ltd
Investigators
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Principal Investigator: Jason Lickliter, MBBS, PhD Nucleus Network

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Responsible Party: Inflazome UK Ltd
ClinicalTrials.gov Identifier: NCT04086602     History of Changes
Other Study ID Numbers: IZD334-001
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cryopyrin-Associated Periodic Syndromes
Syndrome
Disease
Pathologic Processes
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases