#Capsy study skin
#Capsy study verification
#Capsy study trial

Female subjects who are pregnant, currently breastfeeding, or attempting to conceive.

History of or positive screening test for hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II.

Use or intend to use any over-the-counter (vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) or prescription medications within 7 days or 5 half-lives (whichever is longer) prior to receiving study drug, with the exception of hormone replacement therapy and therapies for chronic stable diseases that have been stable for at least 30 days prior to screening and until Day 1, unless deemed acceptable by the investigator.

Use of such medication will be considered on a case-by-case basis as per the opinion of the investigator and/or independent medical monitor, or use of grapefruit or similar substances (Seville oranges or marmalade, grapefruit juice, grapefruit hybrids, pomelos, exotic citrus fruits or fruit juices) within 7 days prior to the Run-in period.

Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes including St John's Wort within 4 weeks prior to receiving study drug and up to end of study.

Subjects who have donated one unit (490 mL) of blood in the past 3 months.

Surgery within last 3 months or planned major surgery within next 3 months from the date of screening (other than minor cosmetic surgery and minor dental surgery).

History or presence of alcohol abuse (alcohol consumption more than 40 g/4 units/4standard drinks per day), or drug habituation, or any prior intravenous usage of an illicit substance.

History of fever, cough or any other active systemic infections within 2 weeks prior to receiving study drug.

History of clinically significant hypersensitivity, intolerance, or allergies, as determined by the investigator.

QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec at screening.

Estimated glomerular filtration rate (eGFR) 1.5 times of ULN at screening.

Any clinically significant laboratory or ECG findings during the screening in the opinion of the Investigator.

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).

#Capsy study trial

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.Male subject must be willing to use contraception and must not donate sperm for at least 90 days after the last dose of study drug.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.Subject must have a body mass index (BMI) between ≥18.0 and ≤38.0 kg/m2 at Screening.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 ). Subject must demonstrate flaring of CAPS de novo or after discontinuation of anti-IL-1 inhibitor treatment.Subject must be willing to discontinue current anti-IL-1 treatment prior to study drug dosing if applicable.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.

#Capsy study verification

Documented verification of a genetic mutation in NLRP3.

#Capsy study skin

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.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: Why Should I Register and Submit Results?.