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Recruiting Phase 1 NCT07007546

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants

Trial Parameters

Condition Healthy
Sponsor Abbisko Therapeutics Co, Ltd
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 42
Sex ALL
Min Age 18 Years
Max Age 45 Years
Start Date 2025-05-17
Completion 2025-08-30
Interventions
ABSK061ABSK061ABSK061

Brief Summary

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 Criteria

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 chi

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