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

Launched by ABBISKO THERAPEUTICS CO, LTD · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ABSK061, which comes in the form of mini-tablets. The main goal is to see how safe the medication is, how well it is tolerated by healthy adults, and how the body processes it after taking it. Researchers are also interested in understanding how eating soft foods along with the mini-tablets may affect how the medication works in the body.

To participate in this study, you must be a healthy adult between the ages of 18 and 45. Males should weigh at least 50 kg, and females should weigh at least 45 kg, with a healthy body mass index (BMI) in the range of 19.0 to 26.0. If you decide to join, you will need to follow specific study procedures and sign a consent form. The trial is currently looking for participants and aims to ensure that the medication is safe and effective. If you have certain health conditions or are planning to start a family during the study, you may not be eligible. Participants can expect regular check-ins and monitoring throughout the trial.

Gender

ALL

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 child while enrolled in this study