Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

Healthy 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 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015076
• Other study ID #: IZD174-001
• Status: Completed
• Phase: Phase 1
• Start date: July 16, 2019
• Est. completion date: March 23, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 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;

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;

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Inzomelid
Active Drug
• Placebo
Placebo to Match

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Queensland

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 advert events [Safety and Tolerability]	Incidence, frequency and severity of treatment emergent advert events	Day 1-8 for SAD, 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
Primary	Peak Plasma Concentration (Cmax)-multiple dose	Peak plasma concentration following multiple dose administration	Days 1-16
Primary	Area under the plasma concentration versus time curve (AUC)- multiple dose	AUC following multiple dose administration	Days 1-16
Secondary	Pharmacodynamic activity	NLRP3 Inhibition in whole blood	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	Days 1-15