| Eligibility |
Inclusion Criteria:
1. Is male or female, between 18 and 65 years of age (inclusive) at Screening;
2. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) at Screening
3. Is in good general health, as determined by the Investigator, without clinically
significant medical history;
4. Normal physical examination, 12-lead electrocardiogram (ECG), and vital signs, as
determined by the Investigator;
5. Clinical laboratory values within the normal limits as defined by the clinical
laboratory reference range;
6. Female partners of male participants of childbearing potential, and female
participants of childbearing potential must agree to use a highly effective method of
contraception prior to study entry, for the duration of study participation, and a
minimum of 30 days after the last dose. Highly effective forms of contraception
include the following:
- Established use (i.e., at least 30 days prior to enrollment) of combined
(estrogen and progestogen containing) oral, intravaginal or transdermal hormonal
contraception associated with inhibition of ovulation,
- Established use (i.e., at least 30 days prior to enrollment) progestogen-only
oral, injectable or implantable hormonal contraception associated with inhibition
of ovulation,
- Established use (i.e., at least 30 days prior to enrollment) of an intrauterine
device (IUD) or intrauterine hormone-releasing system (IUS),
- bilateral tubal occlusion,
- vasectomized partner, provided that partner is the sole sexual partner of the
female trial participant and that the vasectomized partner has received medical
assessment of the surgical success,
- sexual abstinence, defined as refraining from heterosexual intercourse during the
study, when this is in line with the preferred and usual lifestyle of the
subject.
7. In the case of a female of childbearing potential, has a negative serum pregnancy test
(SPT) at Screening and Day -2 and is willing to submit to a SPT at the end of study
(EOS);
8. Negative urine test for drugs of abuse and breath test for alcohol use at Screening
and check-in (Day -2). The tests may be repeated once if necessary and deemed
appropriate by the Investigator;
9. Agree to refrain from tobacco or nicotine containing products within 48 hours prior to
Day 1 and during the periods when PK blood samples are collected;
10. Agree to refrain from alcohol consumption within 48 hours prior to Day 1 and during
the periods when PK blood samples are collected;
11. Agree to refrain from caffeine (i.e., coffee, tea, caffeinated soda, chocolate) within
48 hours prior to Day 1 and during the periods when PK blood samples are collected;
12. Agree to refrain from grapefruit, Seville oranges, and pomelo containing products
within 72 hours prior to Day 1 and during the periods when PK blood samples are
collected; and
13. Read, understand, and sign an informed consent.
Exclusion Criteria:
1. A female who is pregnant, plans to become pregnant during the study, or is
breastfeeding a child;
2. Any clinically significant central nervous system, cardiac, pulmonary, renal,
gastrointestinal (GI), endocrinological, respiratory, or metabolic conditions (or
history), or other pathological or physiological conditions, that might interfere with
the study results in the investigator's opinion;
3. Any condition which, in the investigator's opinion, puts the participant at
significant risk, could confound the study results, or may interfere significantly
with the subject's participation in the study;
4. Immunization within 10 days of Day 1;
5. Anticipated need for surgery or hospitalization during the study;
6. Consumed alcohol within 48 hours prior to Day 1 or refuses to abstain from alcohol
throughout the duration of the study;
7. History of heavy smoking (i.e., more than 10 cigarettes a day or the tobacco/nicotine
equivalent) within 3 months of screening or refuses to abstain from tobacco or
nicotine-containing products throughout the duration of the study;
8. Donation or loss of blood (excluding volume drawn at screening) of = 450 mL within 3
months of Day 1;
9. Active or lifetime infection (e.g., negative test for human immunodeficiency virus
(HIV) and hepatitis, and no history of tuberculosis and syphilis) or a history of
severe infection during the 30 days prior to screening;
10. Chronic or current active infectious disease requiring systemic antibiotics,
antifungal, or antiviral treatment;
11. Prior treatment with a NLRP3 inhibitor for any indication;
12. Is unwilling or unable to refrain from using prescription medications for 30 days
prior to Day 1 or over the counter medications, herbal preparations, and supplements
for 14 days prior to Day 1 (excluding permitted forms of contraception and occasional
use of acetaminophen [up to 2 g in 24 hours]);
13. Inability or unlikeliness of the participant to comply with the dose schedule and
study evaluations, in the opinion of the investigator;
14. Is currently participating in any clinical trial;
15. Has received any investigational drug(s) within 30 days or 5 half-lives, whichever is
longer, prior to study Day 1;
16. Any condition that would, in the investigator's judgment, interfere with full
participation in the study, including attending required study visits; pose a
significant risk to the participant; or interfere with interpretation of study data;
and/or
17. Inability of the participant (or legally authorized representative) to comprehend the
informed consent form (ICF) or unwillingness to sign the ICF.
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