Clinical trial NCT07007546: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Abbisko Therapeutics Co, Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 child while enrolled in this study

Primary outcomes:
measure: Pharmacokinetics single-dose Cmax
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics multiple-dose Cmax
timeFrame: Up to 24 hours post-dose
measure: Pharmacokinetics multiple-dose Cmin
timeFrame: Up to 24 hours post-dose
measure: Pharmacokinetics single dose Tmax
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics single and multiple dose AUC
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics multiple-dose RAUC
timeFrame: Up to 24 hours post-dose
measure: Pharmacokinetics multiple-dose RCmax
timeFrame: Up to 24 hours post-dose
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Initiation of study treatment up to 18-days post treatment
measure: Number of participants with abnormal laboratory tests results and abnormal physical exam findings
timeFrame: Initiation of study treatment up to 18-days post treatment
Secondary outcomes:
measure: Pharmacokinetics single dose CL/F
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics single dose Vz/F
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics single dose t1/2
timeFrame: Up to 48 hours post-dose
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Jiangnan University Affiliated Hospital
state: Jiangsu
Study officials:
References: