A First in Human Trial 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 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).

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: THB335 single dose; Drug: THB335 fasted/fed; Drug: THB335 multiple dose; Drug: Single dose placebo; Drug: Placebo fasted/fed; Drug: Multiple dose placebo

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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Third Harmonic Bio; Phone Number: 617-915-6680; Email: info@thirdharmonicbio.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Recruiting
      • QPS Miami
      • Contact: Principle Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THB335 single dose; Single dose of THB335 fasted	Drug: THB335 single dose; Single dose as oral capsule
Experimental: THB335 fasted and fed; Single dose of THB335 fasted and then fed	Drug: THB335 fasted/fed; Single dose fasted and fed as oral capsule
Experimental: THB335 multiple dose; 14 days of multiple ascending doses of THB335	Drug: THB335 multiple dose; Multiple ascending doses oral capsule
Placebo Comparator: Single dose placebo; Single dose of placebo capsule, fasted	Drug: Single dose placebo; Single dose as oral capsule
Placebo Comparator: Fasted and fed placebo; Single dose of placebo capsule fasted and then fed	Drug: Placebo fasted/fed; Single dose fasted and fed as oral capsule
Placebo Comparator: Multiple dose placebo; 14 days of multiple doses of placebo capsule	Drug: Multiple dose placebo; Multiple doses oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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
Area under the plasma concentration-time curve (AUC)	Part 1, and Part 2 on Day 1. Part 2 on Day 14

Collaborators and Investigators

• Sponsor: Third Harmonic Bio, Inc.
• Investigators: Principal Investigator: Principal Investigator, QPS Holdings LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: THB335-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No