A First in Human Trial Evaluating THB335 in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425861
• Other study ID #: THB335-101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: May 2024
• Source: Third Harmonic Bio, Inc.
• Contact: Third Harmonic Bio
• Phone: 617-915-6680
• Email: info[@]thirdharmonicbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• THB335 single dose
Single dose as oral capsule
• Single dose placebo
Single dose as oral capsule
• THB335 fasted/fed
Single dose fasted and fed as oral capsule
• Placebo fasted/fed
Single dose fasted and fed as oral capsule
• THB335 multiple dose
Multiple ascending doses oral capsule
• Multiple dose placebo
Multiple doses oral capsule

Locations

Country	Name	City	State
United States	QPS Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Third Harmonic Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum observed plasma concentration (Cmax)		Part 1, and Part 2 on Day 1. Part 2 on Day 14
Secondary	Time to Cmax (Tmax)		Part 1, and Part 2 on Day 1. Part 2 on Day 14
Secondary	Area under the plasma concentration-time curve (AUC)		Part 1, and Part 2 on Day 1. Part 2 on Day 14