Evaluating THB335 in healthy participants
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
This study is testing a new drug called THB335 in healthy people to see if it’s safe and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Third Harmonic Bio, Inc. Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06425861 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 clinical trial designed to assess the safety and pharmacokinetics of THB335, a selective inhibitor of the receptor tyrosine kinase KIT, in healthy individuals. The study consists of two parts: the first part involves single ascending doses and evaluating the food effect, while the second part focuses on multiple ascending doses. Participants will be randomly assigned to receive either THB335 or a placebo, and the study will monitor various health parameters to determine the drug's effects. The trial aims to gather essential data on how the drug behaves in the body and its safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18 to 65 with a body weight of at least 50 kg for men and 45 kg for women.
Not a fit: Patients with significant medical histories or conditions that could affect their health or the study's outcomes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of THB335, potentially leading to new treatments for conditions related to mast cell activation.
How similar studies have performed: While this approach is novel in the context of THB335, similar studies evaluating selective inhibitors have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- QPS Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Principal Investigator — QPS Holdings LLC
- Study coordinator: Third Harmonic Bio
- Email: info@thirdharmonicbio.com
- Phone: 617-915-6680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.