This study is a double blind, randomized, placebo-controlled, Phase 1 study in three parts: single ascending doses and food effect (Part 1), multiple ascending doses (Part 2) and Relative Bioavailability of Two Formulations (Part 3).
THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells. The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Single dose as oral capsule
Single dose as oral capsule
Single dose fasted and fed as oral capsule
QPS Miami
Miami, Florida, United States
Number of Participants with Treatment-Related Adverse Events
Time frame: Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study)
Maximum observed plasma concentration (Cmax)
Time frame: Part 1, and Part 2 on Day 1. Part 2 on Day 14
Time to Cmax (Tmax)
Time frame: Part 1, and Part 2 on Day 1. Part 2 on Day 14
Area under the plasma concentration-time curve (AUC)
Time frame: Part 1, and Part 2 on Day 1. Part 2 on Day 14
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Single dose fasted and fed as oral capsule
Multiple ascending doses oral capsule
Multiple doses oral capsule