ABSK061 mini-tablet safety and how the body handles it in healthy adults

A Study 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

This test will try oral ABSK061 mini-tablets in healthy adults to check safety, tolerability, and how the body absorbs the drug, including whether taking them with soft food changes absorption.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Abbisko Therapeutics Co, Ltd (Industry-sponsored)
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT07007546 on ClinicalTrials.gov

What this trial studies

This Phase 1, single- and multiple-dose pharmacokinetic and safety study enrolls healthy adults aged 18–45 to characterize how ABSK061 mini-tablets are absorbed, distributed, and cleared. Participants will receive one or more oral doses with serial blood sampling and safety monitoring, and a separate dosing condition will examine the effect of soft food on pharmacokinetics. Standard safety assessments (vitals, lab tests, and adverse event reporting) will be used and individuals with medical conditions or factors affecting absorption are excluded. The trial is sponsored by Abbisko Therapeutics and conducted at Jiangnan University Affiliated Hospital in Wuxi, Jiangsu, China.

Who should consider this trial

Good fit: Healthy men and women aged 18–45 with BMI 19–26 kg/m2 and meeting the study's weight criteria who have no significant medical history and can consent and comply with procedures are ideal candidates.

Not a fit: People with significant medical, ocular, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, or allergic conditions, pregnant people, or those outside the specified age/weight/BMI ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could define safe dosing ranges and absorption characteristics to guide future patient studies and dosing decisions.

How similar studies have performed: Pharmacokinetic and safety studies in healthy volunteers are a standard, well-established first-in-human approach for small molecules and have routinely informed dose selection for later trials, although ABSK061 itself appears to be a novel compound.

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

Where this trial is running

Wuxi, Jiangsu

• Jiangnan University Affiliated Hospital — Wuxi, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yuan Lu, Doctor

Conditions Healthy