A First in Human Trial Evaluating THB335 in Healthy Participants

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Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo fasted/fed; Drug: THB335 fasted/fed; Drug: THB335 multiple dose; Drug: Multiple dose placebo; Drug: Single dose placebo; Drug: THB335 single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06425861

THB335-101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 6 patient groups, including a placebo group

THB335 single dose

Experimental group

Description:

Single dose of THB335 fasted

Treatment:

Drug: THB335 single dose

THB335 fasted and fed

Experimental group

Description:

Single dose of THB335 fasted and then fed

Treatment:

Drug: THB335 fasted/fed

THB335 multiple dose

Experimental group

Description:

14 days of multiple ascending doses of THB335

Treatment:

Drug: THB335 multiple dose

Single dose placebo

Placebo Comparator group

Description:

Single dose of placebo capsule, fasted

Treatment:

Drug: Single dose placebo

Fasted and fed placebo

Placebo Comparator group

Description:

Single dose of placebo capsule fasted and then fed

Treatment:

Drug: Placebo fasted/fed

Multiple dose placebo

Placebo Comparator group

Description:

14 days of multiple doses of placebo capsule

Treatment:

Drug: Multiple dose placebo