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

NCT07007546 | Recruiting Phase 1

• 1 other identifier: ABSK061-102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetics single-dose Cmax

  maximum plasma concentration (Cmax)

  Up to 48 hours post-dose

• Pharmacokinetics multiple-dose Cmax

  maximum steady-state plasma concentration (Cmax)

  Up to 24 hours post-dose

• Pharmacokinetics multiple-dose Cmin

  average steady-state trough plasma concentration (Cmin)

  Up to 24 hours post-dose

• Pharmacokinetics single dose Tmax

  time to reach maximum plasma concentration (Tmax)

  Up to 48 hours post-dose

• Pharmacokinetics single and multiple dose AUC

  area under the plasma concentration-time curve (AUC)

  Up to 48 hours post-dose

• Pharmacokinetics multiple-dose RAUC

  accumulation ratio for AUC

  Up to 24 hours post-dose

• Pharmacokinetics multiple-dose RCmax

  accumulation ratio for Cmax (RCmax)

  Up to 24 hours post-dose

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

  number of participants with adverse events (AEs), serious adverse events (SAEs), as a measure of safety and tolerability

  Initiation of study treatment up to 18-days post treatment

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

  Frequency in changes in laboratory parameters and physical signs of toxicity

  Initiation of study treatment up to 18-days post treatment

Secondary Outcomes (3)

• Pharmacokinetics single dose CL/F

  Up to 48 hours post-dose

• Pharmacokinetics single dose Vz/F

  Up to 48 hours post-dose

• Pharmacokinetics single dose t1/2

  Up to 48 hours post-dose

Study Arms (3)

Single oral dose of ABSK061

EXPERIMENTAL

Pharmacokinetic profile (PK) and safety of a single oral dose

Drug: ABSK061

Multiple oral doses of ABSK061

EXPERIMENTAL

The safety, tolerability, and PK profile of multiple oral doses of ABSK061

Drug: ABSK061

Food Effect on ABSK061

EXPERIMENTAL

Food Effect Tablet Formulation

Drug: ABSK061

Interventions

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.

Single oral dose of ABSK061

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, 214062, China

RECRUITING

Central Study Contacts

Yuan Lu, Doctor

CONTACT

13816094024; yuan.lu@abbisko.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 6, 2025
• Study Start: May 17, 2025
• Primary Completion: August 30, 2025
• Study Completion: November 30, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

CN (1)