## Protocol Section
### Identification Module
**NCT ID:** NCT06425861

**Brief Title:** A First in Human Trial Evaluating THB335 in Healthy Participants

**Official Title:** 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

#### Organization Study ID Info
**ID:** THB335-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Third Harmonic Bio, Inc.
### Status Module
#### Completion Date
**Date:** 2025-03-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Third Harmonic Bio, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 56

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Single dose of THB335 fasted

**Intervention Names:**

- Drug: THB335 single dose

**Label:** THB335 single dose

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Single dose of THB335 fasted and then fed

**Intervention Names:**

- Drug: THB335 fasted/fed

**Label:** THB335 fasted and fed

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 14 days of multiple ascending doses of THB335

**Intervention Names:**

- Drug: THB335 multiple dose

**Label:** THB335 multiple dose

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Single dose of placebo capsule, fasted

**Intervention Names:**

- Drug: Single dose placebo

**Label:** Single dose placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 5

**Description:** Single dose of placebo capsule fasted and then fed

**Intervention Names:**

- Drug: Placebo fasted/fed

**Label:** Fasted and fed placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 6

**Description:** 14 days of multiple doses of placebo capsule

**Intervention Names:**

- Drug: Multiple dose placebo

**Label:** Multiple dose placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- THB335 single dose

**Description:** Single dose as oral capsule

**Name:** THB335 single dose

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Single dose placebo

**Description:** Single dose as oral capsule

**Name:** Single dose placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- THB335 fasted and fed

**Description:** Single dose fasted and fed as oral capsule

**Name:** THB335 fasted/fed

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Fasted and fed placebo

**Description:** Single dose fasted and fed as oral capsule

**Name:** Placebo fasted/fed

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- THB335 multiple dose

**Description:** Multiple ascending doses oral capsule

**Name:** THB335 multiple dose

**Type:** DRUG

#### Intervention 6

**Arm Group Labels:**

- Multiple dose placebo

**Description:** Multiple doses oral capsule

**Name:** Multiple dose placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of Participants with Treatment-Related Adverse Events

**Time Frame:** Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study)

#### Secondary Outcomes

**Measure:** Maximum observed plasma concentration (Cmax)

**Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14

**Measure:** Time to Cmax (Tmax)

**Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14

**Measure:** Area under the plasma concentration-time curve (AUC)

**Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14

### Eligibility Module

**Eligibility 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** info@thirdharmonicbio.com

**Name:** Third Harmonic Bio

**Phone:** 617-915-6680

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Miami

**Contacts:**

***Contact 1:***

- **Name:** Principle Investigator

- **Role:** CONTACT

**Country:** United States

**Facility:** QPS Miami

**State:** Florida

**Status:** RECRUITING

**Zip:** 33143

#### Overall Officials

**Official 1:**

**Affiliation:** QPS Holdings LLC

**Name:** Principal Investigator

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
