A First in Human Trial Evaluating THB335 in Healthy Participants

Last updated: May 21, 2024
Sponsor: Third Harmonic Bio, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Single dose placebo

Placebo fasted/fed

Multiple dose placebo

Clinical Study ID

NCT06425861
THB335-101
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • In good health, determined by no clinically significant findings from medicalhistory, 12 lead electrocardiogram (ECG), vital sign measurements, and clinicallaboratory 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 anddated written informed consent in accordance with local regulations before theconduct 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

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 duringthe study

  • A positive urine drug screen/alcohol breath test

  • The participant currently smokes, vapes, or uses nicotine-containing products.

Study Design

Total Participants: 56
Treatment Group(s): 6
Primary Treatment: Single dose placebo
Phase: 1
Study Start date:
May 02, 2024
Estimated Completion Date:
March 15, 2025

Study 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.

Connect with a study center

  • QPS Miami

    Miami, Florida 33143
    United States

    Active - Recruiting

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