Actively Recruiting

Phase 1
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT07007546

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

Led by Abbisko Therapeutics Co, Ltd · Updated on 2025-06-06

42

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants
  • Age between 18 and 45 years inclusive
  • Weight: males  50.0 kg, females  45.0 kg
  • Body mass index (BMI) between 19.0 and 26.0 kg/m2 inclusive
  • Able to understand study procedures and willing to voluntarily participate and sign informed consent
Not Eligible

You will not qualify if you...

  • History of significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, musculoskeletal, or allergic diseases
  • Any eye condition that may increase risk of eye toxicity
  • Gastrointestinal disorders affecting oral administration or absorption of ABSK061
  • Females of child-bearing potential and males planning to father a child during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, China, 214062

Actively Recruiting

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Research Team

Y

Yuan Lu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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