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THB335 single dose

Phase 1

Undisclosed | Small molecule | Other |Third Harmonic Bio, Inc.|Trials Updated: Dec 19, 2025

THB335 single dose development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2024

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

THB335 single dose clinical trials

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
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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?

THB335 is an investigational small molecule drug being developed by Third Harmonic Bio, Inc. It has been studied in a first-in-human Phase 1 clinical trial in healthy adult participants. The specific disease indications for which THB335 is being developed have not been publicly disclosed.

Who is developing THB335?

THB335 is being developed by Third Harmonic Bio, Inc., which trades on the Nasdaq under the ticker symbol THRD. The company sponsored the first-in-human Phase 1 trial of THB335 conducted in the United States.

What phase is THB335 in?

THB335 is in Phase 1 clinical development. Its single clinical trial, a first-in-human study in healthy participants, has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is THB335 in?

THB335 has been evaluated in one clinical trial, NCT06425861, titled A First in Human Trial Evaluating THB335 in Healthy Participants. The Phase 1 study enrolled 60 healthy adults aged 18 years and older in the United States and has been completed.

How was the THB335 Phase 1 trial designed?

The Phase 1 trial of THB335, NCT06425861, was a randomized, double-blind, placebo-controlled study in 60 healthy adult participants. It enrolled both male and female volunteers aged 18 years and older at sites in the United States and has been completed.