Healthy
Conditions
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.
Interventions
DRUGInzomelid
Active Drug
DRUGPlacebo
Placebo to Match
Sponsors
Inflazome UK Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax)-single dose | Day 1-3 | Peak plasma concentration following single dose administration |
| Peak Plasma Concentration (Cmax)-multiple dose | Days 1-9 | Peak plasma concentration following multiple dose administration |
| Area under the plasma concentration versus time curve (AUC)- multiple dose | Days 1-9 | AUC following multiple dose administration |
| Incidence of treatment emergent advert events [Safety and Tolerability] | Day 1-8 for SAD, Day 1-16 for MAD | Incidence, frequency and severity of treatment emergent advert events |
| Area under the plasma concentration versus time curve (AUC)- single dose | Day 1-3 | AUC following single dose administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in CAPS symptom scores | Days 1-15 | Reduction in Physician Assessed CAPS scores based on 8 point questionnaire |
| Pharmacodynamic activity | Day 1-3 for SAD and Day 1-9 for MAD | NLRP3 Inhibition in whole blood |
Countries
Australia
Outcome results
None listed