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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single oral dose of ABSK061 | Experimental | Pharmacokinetic profile (PK) and safety of a single oral dose |
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| Multiple oral doses of ABSK061 | Experimental | The safety, tolerability, and PK profile of multiple oral doses of ABSK061 |
|
| Food Effect on ABSK061 | Experimental | Food Effect Tablet Formulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics single dose CL/F | apparent total clearance (CL/F) | Up to 48 hours post-dose |
| Pharmacokinetics single dose Vz/F | apparent volume of distribution (Vz/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangnan University Affiliated Hospital | Wuxi | Jiangsu | 214062 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2025 | May 14, 2025 | Prot_000.pdf |
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| ABSK061 | Drug | 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. |
|
| ABSK061 | Drug | 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). |
|
| 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 |
| Up to 48 hours post-dose |
| Pharmacokinetics single dose t1/2 | half-life of ABSK061 | Up to 48 hours post-dose |