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

Abbisko Therapeutics Co, Ltd42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ABSK061DRUG

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.

ABSK061DRUG

A total of 12 healthy participants were planned to be enrolled in Part II, with multiple dose escalation trials prespecified in Sequences D and E, with 6 healthy participants in each sequence. In this MAD study, participants in Sequence D received ABSK061 microchips 5 mg QD(once a day) for 4 consecutive days.

ABSK061DRUG

Part III plans to include 12 healthy participants randomized 1: 1: 1 to Sequence F, Sequence G, or Sequence H to receive a single oral dose of ABSK061 in triplicate doses of Treatment 1, Treatment 2, Treatment 3. Treatment 1 is 5 mg ABSK061 taken with 180 mL of water, Treatment 2 is 5 mg ABSK061 taken with a spoon of yogurt (approximately 15 mL), and Treatment 3 is administered with 5 mg ABSK061 with a spoon of applesauce (approximately 15 mL).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, China

Outcomes

Primary Outcomes

Pharmacokinetics single-dose Cmax

maximum plasma concentration (Cmax)

Time frame: Up to 48 hours post-dose

Pharmacokinetics multiple-dose Cmax

maximum steady-state plasma concentration (Cmax)

Time frame: Up to 24 hours post-dose

Pharmacokinetics multiple-dose Cmin

average steady-state trough plasma concentration (Cmin)

Time frame: Up to 24 hours post-dose

Pharmacokinetics single dose Tmax

time to reach maximum plasma concentration (Tmax)

Time frame: Up to 48 hours post-dose

Pharmacokinetics single and multiple dose AUC

area under the plasma concentration-time curve (AUC)

Time frame: Up to 48 hours post-dose

Pharmacokinetics multiple-dose RAUC

accumulation ratio for AUC

Time frame: Up to 24 hours post-dose

Pharmacokinetics multiple-dose RCmax

accumulation ratio for Cmax (RCmax)

Time frame: 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

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

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

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes