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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: ABSK061

• Registration Number: NCT07007546
• Lead Sponsor: Abbisko Therapeutics Co, Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-14
• Study Start: 2025-05-17
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2025-08-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single oral dose of ABSK061	ABSK061	Pharmacokinetic profile (PK) and safety of a single oral dose
Food Effect on ABSK061	ABSK061	Food Effect Tablet Formulation
Multiple oral doses of ABSK061	ABSK061	The safety, tolerability, and PK profile of multiple oral doses of ABSK061

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics multiple-dose Cmax	Up to 24 hours post-dose	maximum steady-state plasma concentration (Cmax)
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
Pharmacokinetics single-dose Cmax	Up to 48 hours post-dose	maximum 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
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

Secondary Outcome Measures

Name	Time	Method
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
Pharmacokinetics single dose Vz/F	Up to 48 hours post-dose	apparent volume of distribution (Vz/F)

Trial Locations

Locations (1)

Jiangnan University Affiliated Hospital; 🇨🇳 Wuxi, Jiangsu, China