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Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04015076
Recruitment Status : Completed
First Posted : July 10, 2019
Last Update Posted : March 27, 2020
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 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Inzomelid Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 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
Actual Study Start Date : July 16, 2019
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 23, 2020


Arm Intervention/treatment
Experimental: Single Ascending Dose
Inzomelid or Placebo
Drug: Inzomelid
Active Drug

Drug: Placebo
Placebo to Match

Experimental: Multiple Ascending Dose
Inzomelid or Placebo
Drug: Inzomelid
Active Drug

Drug: Placebo
Placebo to Match

Experimental: Patients with CAPS
Inzomelid Open Label
Drug: Inzomelid
Active Drug




Primary Outcome Measures :
  1. 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

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

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

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

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

  6. Peak Plasma Concentration (Cmax)-multiple dose [ Time Frame: Days 1-16 ]
    Peak plasma concentration following multiple dose administration

  7. Area under the plasma concentration versus time curve (AUC)- multiple dose [ Time Frame: Days 1-16 ]
    AUC following multiple dose administration


Secondary Outcome Measures :
  1. Pharmacodynamic activity [ Time Frame: Day 1-3 for SAD and Day 1-9 for MAD ]
    NLRP3 Inhibition in whole blood

  2. Reduction in CAPS symptom scores [ Time Frame: Days 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 70 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;

Inclusion Criteria- CAPS Patients:

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

Exclusion Criteria- Healthy Volunteers:

  • 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;

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.

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;


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): NCT04015076


Locations
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Australia, Queensland
Nucleus Network
Melbourne, Queensland, Australia
Sponsors and Collaborators
Inflazome UK Ltd
Investigators
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Principal Investigator: Ben Snyder, MB, BS Nucleus Network
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Responsible Party: Inflazome UK Ltd
ClinicalTrials.gov Identifier: NCT04015076    
Other Study ID Numbers: IZD174-001
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: February 2020
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