A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Z… (NCT05186051) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS)
Australia3 participantsStarted 2022-06-01
Plain-language summary
ZYIL1 is expected to show benefit in patients with CAPS. The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with CAPS.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects with a confirmed diagnosis of CAPS (FCAS, NOMID, or MWS) aged 18 to 75 years inclusive at screening A confirmed diagnosis of CAPS comprises the following:
✓. Subject has previously experienced at least 2 typical clinical symptoms of CAPS (may include urticarial skin rash, myalgia, arthralgia, recurrent fever, fatigue/malaise, headache, conjunctivitis, and any other autoinflammatory symptom); and
✓. Documented verification of a genetic mutation in NLRP3.
✓. Positive response of ZYIL1 in inhibiting secreted IL-1β from peripheral blood mononuclear cells isolated from the subject's blood treated with LPS ex vivo showing half maximal inhibitory concentration below 500 nM.
✓. Subject must be willing to discontinue current anti-IL-1 treatment prior to study drug dosing if applicable.
✓. Subject must demonstrate flaring of CAPS de novo or after discontinuation of anti-IL-1 inhibitor treatment. Flaring is defined as worsening of disease activity as per physician global assessment of disease activity with elevation of CRP (\>2 x upper limit of normal \[ULN\]).
✓. Subject must have a body mass index (BMI) between ≥18.0 and ≤38.0 kg/m2 at Screening.
✓. Female subject of reproductive age must be non-pregnant and non-lactating, and must use an acceptable, highly effective contraception from screening until 1 month after the last dose of study drug.
Exclusion criteria
✕. Any severe, progressive, or uncontrolled medical condition within the past 3 months that might have impact on the clinical trial as per the investigator's discretion.
✕. Use of any investigational drug or investigational medical device or participation in other clinical study within 4 weeks prior to Screening or 5 half- lives of the product (whichever is longer).
✕. Any clinically significant laboratory or ECG findings during the screening in the opinion of the Investigator.
✕. Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2, as measured by the Cockcroft-Gault equation at screening
✕. Total bilirubin above upper limit of normal (ULN) or AST(SGOT)/ALT(SGPT) \> 1.5 times of ULN at screening
✕. QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 msec at screening
✕. History of clinically significant hypersensitivity, intolerance, or allergies, as determined by the investigator.
✕. History of fever, cough or any other active systemic infections within 2 weeks prior to receiving study drug.