Healthy
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGTHB335 single dose
Single dose as oral capsule
Single dose as oral capsule
DRUGTHB335 fasted/fed
Single dose fasted and fed as oral capsule
DRUGPlacebo fasted/fed
Single dose fasted and fed as oral capsule
DRUGTHB335 multiple dose
Multiple ascending doses oral capsule
DRUGMultiple dose placebo
Multiple doses oral capsule
Sponsors
Third Harmonic Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations * Males or females, of any race, between 18 and 65 years of age, inclusive. * Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures * Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening
Exclusion criteria
* Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study * A positive urine drug screen/alcohol breath test * The participant currently smokes, vapes, or uses nicotine-containing products.
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC) | Part 1, and Part 2 on Day 1. Part 2 on Day 14 |
| 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 |
Countries
United States
Outcome results
None listed