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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THB335 single dose | Experimental | Single dose of THB335 fasted |
|
| THB335 fasted and fed | Experimental | Single dose of THB335 fasted and then fed |
|
| THB335 multiple dose | Experimental | 14 days of multiple ascending doses of THB335 |
|
| Single dose placebo | Placebo Comparator | Single dose of placebo capsule, fasted |
|
| Fasted and fed placebo | Placebo Comparator | Single dose of placebo capsule fasted and then fed |
|
| Multiple dose placebo | Placebo Comparator | 14 days of multiple doses of placebo capsule |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THB335 single dose | Drug | Single dose as oral capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events | Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Part 1, and Part 2 on Day 1. Part 2 on Day 14 | |
| Time to Cmax (Tmax) | Part 1, and Part 2 on Day 1. Part 2 on Day 14 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | QPS Holdings LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Miami | Miami | Florida | 33143 | United States |
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| Single dose placebo |
| Drug |
Single dose as oral capsule |
|
| THB335 fasted/fed | Drug | Single dose fasted and fed as oral capsule |
|
| Placebo fasted/fed | Drug | Single dose fasted and fed as oral capsule |
|
| THB335 multiple dose | Drug | Multiple ascending doses oral capsule |
|
| Multiple dose placebo | Drug | Multiple doses oral capsule |
|
| Area under the plasma concentration-time curve (AUC) |
| Part 1, and Part 2 on Day 1. Part 2 on Day 14 |