| Eligibility |
Inclusion Criteria:
1. Adults aged 18 to 55 years (inclusive), of any gender (each dose group should include
at least two subjects of a single gender, except for the 2 mg dose group in Part 1A).
2. Body Mass Index (BMI = weight/height^2) during screening: 19 = BMI < 28 kg/m^2; male
weight = 50.0 kg and < 90.0 kg, female weight = 45.0 kg and < 90.0 kg.
3. Healthy subjects with physical examination, vital signs, and laboratory test results
(including complete blood count, urinalysis, blood biochemistry, coagulation function,
thyroid function), chest X-ray, 12-lead electrocardiogram, abdominal ultrasound,
judged by the investigator as normal or clinically insignificant abnormalities during
screening.
4. Female subjects of reproductive potential and male subjects with female partners of
reproductive potential must have no plans for reproduction, sperm/egg donation for at
least 3 months after the last dose and voluntarily agree to use effective
contraception. Serum pregnancy test for female subjects must be negative and not in
lactation.
5. Obtain informed consent before any trial-related activities begin, fully understand
the purpose and significance of this trial, and be willing to comply with the trial
protocol.
Exclusion Criteria:
1. Within the past year prior to screening or dosing, individuals with systemic diseases
such as cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological,
or hematologic conditions, deemed by the investigator to pose potential safety risks.
2. Within the past 6 months prior to screening or dosing, individuals with a history of
severe infections (such as bloodstream infections, central nervous system infections,
abdominal infections, etc.), severe trauma, or major surgeries (excluding
appendectomy); those planning to undergo surgery during the trial.
3. Within the past month prior to screening or dosing, individuals with a history of
infections (viral, bacterial, fungal, parasitic) requiring systemic antimicrobial
therapy.
4. Individuals experiencing frequent headaches, nausea, and/or vomiting with a frequency
of =3 times per month.
5. Individuals with allergic tendencies, such as a history of asthma, atopic dermatitis,
chronic urticaria, allergic rhinitis, or any known allergies to drugs or foods.
6. Within the past month prior to screening or dosing, individuals who donated blood or
experienced blood loss =200 mL, or within the past 3 months prior to dosing,
individuals who donated blood or experienced blood loss =400 mL.
7. As determined by the study physician, individuals with any physiological or
psychological condition that may increase trial risks, affect subject compliance with
the protocol, or interfere with subject completion of the trial.
8. Individuals with a smoking history within the past 3 months prior to screening
(average daily smoking >5 cigarettes) or those unable to abstain from any tobacco
products during the trial.
9. Within the past month prior to screening, individuals with an average daily alcohol
intake exceeding 7 g for females (equivalent to approximately 200 mL of beer, 70 mL of
wine, or 22 mL of spirits) or exceeding 14 g for males (equivalent to approximately
400 mL of beer, 140 mL of wine, or 45 mL of spirits); or individuals with a positive
alcohol test at screening or those unable to abstain from alcohol during the trial.
10. Individuals who consumed any grapefruit-containing foods or beverages within 7 days
prior to taking the study drug, or those who consumed caffeine-containing foods or
beverages within 2 days prior to taking the study drug.
11. Individuals with special dietary requirements who cannot adhere to a standardized
diet.
12. Individuals with a history of drug abuse or substance misuse, or those with a positive
urine drug screen at screening.
13. Individuals with positive results in infectious disease screening tests (HBsAg,
anti-HCV Ab, anti-TP Ab, anti-HIV Ab) at screening.
14. Individuals with alanine aminotransferase (ALT), aspartate aminotransferase (AST),
alkaline phosphatase (ALP), or total bilirubin (TBIL) levels =1.5 times the upper
limit of normal (ULN) at screening.
15. Within 2 weeks prior to screening or dosing, individuals who used any prescription
medications, over-the-counter medications, or herbal supplements; or individuals
within 5 half-lives of a drug (whichever is longer) at screening or planning to use
non-study investigational drug during the trial.
16. Within the past 3 months prior to screening, individuals who participated in any other
clinical trial (excluding those who failed screening) or those still within 5
half-lives of a drug (whichever is longer) at screening.
17. Within the past 3 months prior to screening, individuals who received a live vaccine
or attenuated live vaccine, or those planning to receive any vaccines during the
trial.
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