Healthy
Conditions
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
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.
Sponsors
Abbisko Therapeutics Co, Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal laboratory tests results and abnormal physical exam findings | Initiation of study treatment up to 18-days post treatment | Frequency in changes in laboratory parameters and physical signs of toxicity |
| Pharmacokinetics single-dose Cmax | Up to 48 hours post-dose | maximum plasma concentration (Cmax) |
| Pharmacokinetics multiple-dose Cmax | Up to 24 hours post-dose | maximum steady-state plasma concentration (Cmax) |
| Pharmacokinetics multiple-dose Cmin | Up to 24 hours post-dose | average steady-state trough plasma concentration (Cmin) |
| Pharmacokinetics single dose Tmax | Up to 48 hours post-dose | time to reach maximum plasma concentration (Tmax) |
| Pharmacokinetics single and multiple dose AUC | Up to 48 hours post-dose | area under the plasma concentration-time curve (AUC) |
| Pharmacokinetics multiple-dose RAUC | Up to 24 hours post-dose | accumulation ratio for AUC |
| Pharmacokinetics multiple-dose RCmax | Up to 24 hours post-dose | accumulation ratio for Cmax (RCmax) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Initiation of study treatment up to 18-days post treatment | number of participants with adverse events (AEs), serious adverse events (SAEs), as a measure of safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics single dose Vz/F | Up to 48 hours post-dose | apparent volume of distribution (Vz/F) |
| Pharmacokinetics single dose CL/F | Up to 48 hours post-dose | apparent total clearance (CL/F) |
| Pharmacokinetics single dose t1/2 | Up to 48 hours post-dose | half-life of ABSK061 |
Countries
China
Outcome results
None listed