RecruitingPhase 1NCT07007546

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

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

Sponsor

Abbisko Therapeutics Co, Ltd

Enrollment

42 participants

Start Date

May 17, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

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

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

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 Criteria4

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

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Interventions

DRUGABSK061

A total of 18 healthy participants were planned to be enrolled in Part I and randomized 1: 1: 1 to Sequences A, B, and C. Participants in three sequences received a single dose of ABSK061 at doses of 1 mg, 10 mg, and 35 mg.

DRUGABSK061

A total of 12 healthy participants were planned to be enrolled in Part II, with multiple dose escalation trials prespecified in Sequences D and E, with 6 healthy participants in each sequence. In this MAD study, participants in Sequence D received ABSK061 microchips 5 mg QD(once a day) for 4 consecutive days.

DRUGABSK061

Part III plans to include 12 healthy participants randomized 1: 1: 1 to Sequence F, Sequence G, or Sequence H to receive a single oral dose of ABSK061 in triplicate doses of Treatment 1, Treatment 2, Treatment 3. Treatment 1 is 5 mg ABSK061 taken with 180 mL of water, Treatment 2 is 5 mg ABSK061 taken with a spoon of yogurt (approximately 15 mL), and Treatment 3 is administered with 5 mg ABSK061 with a spoon of applesauce (approximately 15 mL).