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

PHASE1RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 17, 2025

Primary Completion Date

August 30, 2025

Study Completion Date

November 30, 2025

Conditions
Healthy
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).

Trial Locations (1)

214062

RECRUITING

Jiangnan University Affiliated Hospital, Wuxi

Sponsors
All Listed Sponsors
lead

Abbisko Therapeutics Co, Ltd

INDUSTRY

NCT07007546 - A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants | Biotech Hunter | Biotech Hunter