Status:
COMPLETED
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334
Lead Sponsor:
Inflazome UK Ltd
Conditions:
Healthy Volunteers
Cryopyrin Associated Periodic Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in a...
Eligibility Criteria
Inclusion
- (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
- Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate
- (CAPS Patients)
- \*Patients with a confirmed diagnosis of CAPS (FCAS or MWS) aged 18 to 65 years (inclusive at the time of informed consent)
Exclusion
- (Healthy volunteer)
- 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
- Blood donation or significant blood loss within 60 days prior to the first study drug administration
Key Trial Info
Start Date :
September 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04086602
Start Date
September 13 2019
End Date
February 4 2020
Last Update
March 2 2020
Active Locations (1)
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1
Nucleus Network
Melbourne, Victoria, Australia