Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

NCT ID: NCT04015076

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-16
• Study Completion Date: 2020-03-23

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.

Conditions

Healthy

Study Design

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

Study Groups

Single Ascending Dose

Inzomelid or Placebo

Group Type: EXPERIMENTAL

Inzomelid

Intervention Type: DRUG

Active Drug

Placebo

Intervention Type: DRUG

Placebo to Match

Multiple Ascending Dose

Inzomelid or Placebo

Group Type: EXPERIMENTAL

Inzomelid

Intervention Type: DRUG

Active Drug

Placebo

Intervention Type: DRUG

Placebo to Match

Patients with CAPS

Inzomelid Open Label

Group Type: EXPERIMENTAL

Inzomelid

Intervention Type: DRUG

Active Drug

Interventions

Inzomelid

Active Drug

Intervention Type: DRUG

Placebo

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;

• 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

• 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;

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inflazome UK Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Snyder, MB, BS

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

Nucleus Network

Melbourne, Queensland, Australia

Countries

Australia

Other Identifiers

IZD174-001

Identifier Type: -

Identifier Source: org_study_id