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RECRUITING
NCT07007546
PHASE1

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

Sponsor: Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

Summary

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

Official title: A Study 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2025-05-17

Completion Date

2025-11-30

Last Updated

2025-06-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

ABSK061

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.

DRUG

ABSK061

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.

DRUG

ABSK061

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).

Locations (1)

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, China