A First in Human Trial Evaluating THB335 in Healthy Participants

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: THB335 single dose; Drug: THB335 fasted/fed; Drug: THB335 multiple dose; Drug: Single dose placebo; Drug: Placebo fasted/fed; Drug: Multiple dose placebo

• Registration Number: NCT06425861
• Lead Sponsor: Third Harmonic Bio, Inc.

Brief Summary

This study is a double blind, randomized, placebo-controlled, Phase 1 study in two parts: single ascending doses and food effect (Part 1) and multiple ascending doses (Part 2).

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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-02
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THB335 single dose	THB335 single dose	Single dose of THB335 fasted
THB335 fasted and fed	THB335 fasted/fed	Single dose of THB335 fasted and then fed
THB335 multiple dose	THB335 multiple dose	14 days of multiple ascending doses of THB335
Single dose placebo	Single dose placebo	Single dose of placebo capsule, fasted
Fasted and fed placebo	Placebo fasted/fed	Single dose of placebo capsule fasted and then fed
Multiple dose placebo	Multiple dose placebo	14 days of multiple doses of placebo capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

QPS Miami; 🇺🇸 Miami, Florida, United States