Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, China, 214062
Actively Recruiting
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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