A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB335 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- THB335 fasted/fed
- Conditions
- Healthy
- Sponsor
- Third Harmonic Bio, Inc.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of Participants with Treatment-Related Adverse Events
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
THB335 fasted and fed
Single dose of THB335 fasted and then fed
Intervention: THB335 fasted/fed
Multiple dose placebo
14 days of multiple doses of placebo capsule
Intervention: Multiple dose placebo
THB335 single dose
Single dose of THB335 fasted
Intervention: THB335 single dose
THB335 multiple dose
14 days of multiple ascending doses of THB335
Intervention: THB335 multiple dose
Single dose placebo
Single dose of placebo capsule, fasted
Intervention: Single dose placebo
Fasted and fed placebo
Single dose of placebo capsule fasted and then fed
Intervention: Placebo fasted/fed
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Maximum observed plasma concentration (Cmax)(Part 1, and Part 2 on Day 1. Part 2 on Day 14)
- Area under the plasma concentration-time curve (AUC)(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)