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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants
Sponsor: Abbisko Therapeutics Co, Ltd
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
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.
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.
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