Overview
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its pharmacokinetic profile in healthy adult participants
Eligibility
Inclusion Criteria:
- Gender:male or female participants, both male and female
- Age: 18 to 45 years (including 18 and 45 years)
- Weight: male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg, and body mass index is in the range of 19.0-26.0 kg/m2 (including cut-off value), and body mass index (BMI) = weight (kg)/height 2 (m2)
- Able to understand and willing to comply with the study procedures, voluntarily participate in this clinical trial and sign the informed consent form before screening
Exclusion Criteria:
- Significant history of any hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, musculoskeletal disease, or allergic disease (as determined by the Investigator)
- Any ocular condition likely to increase the risk of eye toxicity
- Gastrointestinal disorders that will affect oral administration or absorption of ABSK061
- Females of child-bearing potential and males who plan to father a child while enrolled in this study