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Completed

NCT Number: NCT07007546

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

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, 214062, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABSK061

Drug

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.

Primary outcomes

  1. Pharmacokinetics single-dose Cmax

    Time frame: Up to 48 hours post-dose

    maximum plasma concentration (Cmax)

  2. Pharmacokinetics multiple-dose Cmax

    Time frame: Up to 24 hours post-dose

    maximum steady-state plasma concentration (Cmax)

  3. Pharmacokinetics multiple-dose Cmin

    Time frame: Up to 24 hours post-dose

    average steady-state trough plasma concentration (Cmin)

  4. Pharmacokinetics single dose Tmax

    Time frame: Up to 48 hours post-dose

    time to reach maximum plasma concentration (Tmax)

  5. Pharmacokinetics single and multiple dose AUC

    Time frame: Up to 48 hours post-dose

    area under the plasma concentration-time curve (AUC)

  6. Pharmacokinetics multiple-dose RAUC

    Time frame: Up to 24 hours post-dose

    accumulation ratio for AUC

  7. Pharmacokinetics multiple-dose RCmax

    Time frame: Up to 24 hours post-dose

    accumulation ratio for Cmax (RCmax)

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

    Time frame: 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

  9. Number of participants with abnormal laboratory tests results and abnormal physical exam findings

    Time frame: Initiation of study treatment up to 18-days post treatment

    Frequency in changes in laboratory parameters and physical signs of toxicity

Secondary outcomes

  1. Pharmacokinetics single dose CL/F

    Time frame: Up to 48 hours post-dose

    apparent total clearance (CL/F)

  2. Pharmacokinetics single dose Vz/F

    Time frame: Up to 48 hours post-dose

    apparent volume of distribution (Vz/F)

  3. Pharmacokinetics single dose t1/2

    Time frame: Up to 48 hours post-dose

    half-life of ABSK061

Sponsors and collaborators

Lead sponsor

Abbisko Therapeutics Co, Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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