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THB335 single dose

Phase 1

Healthy | Small molecule | Other |Third Harmonic Bio, Inc.|Last Updated: Dec 19, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

THB335 single dose · 1 trial · 1 indication

Phase 1 1
NCT06425861A First in Human Trial Evaluating THB335 in Healthy ParticipantsHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
A First in Human Trial Evaluating THB335 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Maximum observed plasma concentration (Cmax)
Part 1, and Part 2 on Day 1. Part 2 on Day 14
Time to Cmax (Tmax)
Part 1, and Part 2 on Day 1. Part 2 on Day 14
Area under the plasma concentration-time curve (AUC)
Part 1, and Part 2 on Day 1. Part 2 on Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
THB335 single doseEXPERIMENTALSingle dose of THB335 fasted
THB335 fasted and fedEXPERIMENTALSingle dose of THB335 fasted and then fed
THB335 multiple doseEXPERIMENTAL14 days of multiple ascending doses of THB335
Single dose placeboPLACEBO_COMPARATORSingle dose of placebo capsule, fasted
Fasted and fed placeboPLACEBO_COMPARATORSingle dose of placebo capsule fasted and then fed
Multiple dose placeboPLACEBO_COMPARATOR14 days of multiple doses of placebo capsule

Interventions

NameTypeDescription
THB335 single doseDRUGSingle dose as oral capsule
Single dose placeboDRUGSingle dose as oral capsule
THB335 fasted/fedDRUGSingle dose fasted and fed as oral capsule
Placebo fasted/fedDRUGSingle dose fasted and fed as oral capsule
THB335 multiple doseDRUGMultiple ascending doses oral capsule
Multiple dose placeboDRUGMultiple doses oral capsule
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about THB335 single dose

What is THB335 single dose?

THB335 single dose is an investigational small molecule being developed by Third Harmonic Bio, Inc. for use in healthy participants. It is currently in Phase 1 clinical development, with one completed trial evaluating its safety and tolerability.

What does THB335 single dose target?

THB335 single dose is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being studied in a first-in-human trial to evaluate its effects in healthy participants.

Who makes THB335 single dose?

THB335 single dose is being developed by Third Harmonic Bio, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol THRD.

What phase is THB335 single dose in?

THB335 single dose is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is THB335 single dose in?

THB335 single dose has been studied in one clinical trial, NCT06425861, titled 'A First in Human Trial Evaluating THB335 in Healthy Participants.' This Phase 1, randomized, double-blind, placebo-controlled trial enrolled 60 healthy adults in the United States and has been completed.

Is THB335 single dose the same as THB335?

THB335 single dose is a formulation or dosing regimen of the investigational drug THB335. The single dose designation refers to the specific administration schedule being evaluated in clinical trials, while THB335 is the underlying drug candidate.