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History of Changes for Study: NCT04015076
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
Latest version (submitted March 26, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 9, 2019 None (earliest Version on record)
2 July 17, 2019 Recruitment Status, Study Status and Contacts/Locations
3 December 19, 2019 Study Status, Eligibility, Outcome Measures, Arms and Interventions, Study Identification, Study Design and Study Description
4 February 10, 2020 Study Status
5 March 26, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04015076
July 9, 2019 (v1) -- February 10, 2020 (v4)

Changes in: Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: IZD174-001 IZD174-001
Brief Title: Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Volunteers Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
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 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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2019 February 2020
Overall Status: Not yet recruitingRecruiting
Study Start: July 2019 July 16, 2019
Primary Completion: December 2019 [Anticipated ] March 2020 [Anticipated ]
Study Completion: December 2019 [Anticipated ] March 2020 [Anticipated ]
First Submitted: July 8, 2019 July 8, 2019
First Submitted that
Met QC Criteria:
July 9, 2019 July 9, 2019
First Posted: July 10, 2019 [Actual ] July 10, 2019 [Actual ]
Last Update Submitted that
Met QC Criteria:
July 9, 2019 February 10, 2020
Last Update Posted: July 10, 2019 [Actual ] February 12, 2020 [Actual ]
Open or close this module Sponsor/Collaborators
Sponsor: Inflazome UK Ltd Inflazome UK Ltd
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: NoNo
U.S. FDA-regulated Device: NoNo
Data Monitoring: No No
Open or close this module Study Description
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. Oversight will be provided by a safety monitoring committee (SMC) comprised of the Investigator, the Sponsor's Medical Monitor and an Independent Medical Monitor. 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.
Detailed Description:
Open or close this module Conditions
Conditions: Healthy Healthy
Keywords:
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: OtherOther
Study Phase: Phase 1Phase 1
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 23
Masking: Double (Participant, Investigator)Double (Participant, Investigator)
Allocation: RandomizedRandomized
Enrollment: 72 [Anticipated ] 85 [Anticipated ]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of treatment emergent advert events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent advert events

[Time Frame: Day 1-8 for SAD, Day 1-16 for MAD ]
Incidence of treatment emergent advert events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent advert events

[Time Frame: Day 1-8 for SAD, Day 1-16 for MAD ]
2. Peak Plasma Concentration (Cmax)-single dose
Peak plasma concentration following single dose administration

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

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

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

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

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

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

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

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

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

[Time Frame: Days 1-16 ]
Secondary Outcome Measures:
8. Pharmacodynamic activity
NLRP3 Inhibition in whole blood

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

[Time Frame: Day 1-3 for SAD and Day 1-9 for MAD ]
9. Reduction in CAPS symptom scores
Reduction in Physician Assessed CAPS scores based on 8 point questionnaire

[Time Frame: Days 1-15 ]
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 65 Years 70 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: YesYes
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;

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;

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;

Open or close this module Contacts/Locations
Central Contact Person: Jeff Thompson, PhD, MBA
Telephone: +44(0)1223 751549
Email: j.thompson@inflazome.com
Jeff Thompson, PhD, MBA
Telephone: +44(0)1223 751549
Email: j.thompson@inflazome.com
Central Contact Backup: Thomas Jung, MD, PhD
Telephone: +44(0)1223 751549
Email: t.jung@inflazome.com
Thomas Jung, MD, PhD
Telephone: +44(0)1223 751549
Email: t.jung@inflazome.com
Study Officials: Ben Snyder, MB, BS
Principal Investigator
Nucleus Network
Ben Snyder, MB, BS
Principal Investigator
Nucleus Network
Locations: Australia, Queensland
Nucleus Network
[Recruiting]
Melbourne, Queensland, Australia
Contact:Contact: Ben Snyder, MB BS
Open or close this module IPDSharing
Plan to Share IPD: No No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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