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ABSK021 Food Effect Study in Healthy Subjects

NCT05280483 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-12

No results posted yet for this study

Summary

This is a randomized, open-label, two-sequence, two-cycle, cross-over study to evaluate the relative bioavailability of ABSK021 after single-dose fasting and high-fat postprandial administration in healthy subjects

Conditions

  • Neoplasms

Interventions

DRUG

ABSK021 with fed state

25 mg ABSK021 (1x25 mg ABSK021 capsule) with food

DRUG

ABSK021 with fasted state

25 mg ABSK021 (1x25 mg ABSK021 capsule) without food

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • Jing Zhang · Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-23
Primary Completion
2022-08-31
Completion
2023-05-26
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280483 on ClinicalTrials.gov