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A First in Human Trial Evaluating THB335 in Healthy Participants

NCT ID: NCT06425861

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2024-12-18

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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THB335 single dose

Single dose of THB335 fasted

Group Type EXPERIMENTAL

THB335 single dose

Intervention Type DRUG

Single dose as oral capsule

THB335 fasted and fed

Single dose of THB335 fasted and then fed

Group Type EXPERIMENTAL

THB335 fasted/fed

Intervention Type DRUG

Single dose fasted and fed as oral capsule

THB335 multiple dose

14 days of multiple ascending doses of THB335

Group Type EXPERIMENTAL

THB335 multiple dose

Intervention Type DRUG

Multiple ascending doses oral capsule

Single dose placebo

Single dose of placebo capsule, fasted

Group Type PLACEBO_COMPARATOR

Single dose placebo

Intervention Type DRUG

Single dose as oral capsule

Fasted and fed placebo

Single dose of placebo capsule fasted and then fed

Group Type PLACEBO_COMPARATOR

Placebo fasted/fed

Intervention Type DRUG

Single dose fasted and fed as oral capsule

Multiple dose placebo

14 days of multiple doses of placebo capsule

Group Type PLACEBO_COMPARATOR

Multiple dose placebo

Intervention Type DRUG

Multiple doses oral capsule

Interventions

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THB335 single dose

Single dose as oral capsule

Intervention Type DRUG

Single dose placebo

Single dose as oral capsule

Intervention Type DRUG

THB335 fasted/fed

Single dose fasted and fed as oral capsule

Intervention Type DRUG

Placebo fasted/fed

Single dose fasted and fed as oral capsule

Intervention Type DRUG

THB335 multiple dose

Multiple ascending doses oral capsule

Intervention Type DRUG

Multiple dose placebo

Multiple doses oral capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Third Harmonic Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

QPS Holdings LLC

Locations

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QPS Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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THB335-101

Identifier Type: -

Identifier Source: org_study_id