CompletedPhase 1

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

China42 participantsStarted 2025-05-17

Plain-language 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

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics single-dose Cmax

Timeframe: Up to 48 hours post-dose

Pharmacokinetics multiple-dose Cmax

Timeframe: Up to 24 hours post-dose

Pharmacokinetics multiple-dose Cmin

Timeframe: Up to 24 hours post-dose

Pharmacokinetics single dose Tmax

Timeframe: Up to 48 hours post-dose

Pharmacokinetics single and multiple dose AUC

Timeframe: Up to 48 hours post-dose

Pharmacokinetics multiple-dose RAUC

Timeframe: Up to 24 hours post-dose

Pharmacokinetics multiple-dose RCmax

Timeframe: Up to 24 hours post-dose

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial details

NCT IDNCT07007546

SponsorAbbisko Therapeutics Co, Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pharmacokinetics single-dose Cmax

Timeframe: Up to 48 hours post-dose

Pharmacokinetics multiple-dose Cmax

Timeframe: Up to 24 hours post-dose

Pharmacokinetics multiple-dose Cmin

Timeframe: Up to 24 hours post-dose

Pharmacokinetics single dose Tmax

Timeframe: Up to 48 hours post-dose

Pharmacokinetics single and multiple dose AUC

Timeframe: Up to 48 hours post-dose

Pharmacokinetics multiple-dose RAUC

Timeframe: Up to 24 hours post-dose

Pharmacokinetics multiple-dose RCmax

Timeframe: Up to 24 hours post-dose

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]