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

Abbisko Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: ABSK061

Study type: Interventional

Funder types: Industry

Identifiers

NCT07007546

ABSK061-102

Details and patient eligibility

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

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Single oral dose of ABSK061

Experimental group

Description:

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

Treatment:

Drug: ABSK061

Drug: ABSK061

Drug: ABSK061

Multiple oral doses of ABSK061

Experimental group

Description:

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

Treatment:

Drug: ABSK061

Drug: ABSK061

Drug: ABSK061

Food Effect on ABSK061

Experimental group

Description:

Food Effect Tablet Formulation

Treatment:

Drug: ABSK061

Drug: ABSK061

Drug: ABSK061