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LHF-535

Phase 1

Healthy | Small molecule | Other |TuHURA Biosciences, Inc.|Last Updated: Jul 9, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

LHF-535 · 1 trial · 1 indication

Phase 1 1
NCT03993704Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy ParticipantsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v4.0
42 days

Safety and tolerability

Secondary Endpoints

Area Under the Plasma Concentration versus Time Curve (AUC) of LHF-535
21 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTAL450 mg, 1125 mg, or 2250 mg of LHF-535 given once daily for 14 days
PlaceboPLACEBO_COMPARATORPlacebo to match LHF-535 given once daily for 14 days

Interventions

NameTypeDescription
LHF-535DRUGOral suspension administered once daily for 14 days
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female 18 to 50 years of age, inclusive, at the time of screening * Able to understand the requirements of the study, to provide written informed consent (as evidenced by signature on an informed consent document that is approved by a Human Research Ethics Committee \[...

Countries:Australia
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Frequently asked questions about LHF-535

What is LHF-535?

LHF-535 is an investigational small molecule being developed by TuHURA Biosciences, Inc. (NASDAQ: HURA). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and it is not yet approved by the FDA.

What is LHF-535 used for?

LHF-535 is being studied for use in healthy participants. It has undergone a Phase 1 clinical trial to evaluate its safety and tolerability. The drug is investigational and has not been approved for any medical condition.

Who makes LHF-535?

LHF-535 is being developed by TuHURA Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol HURA. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics.

What phase is LHF-535 in?

LHF-535 is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy participants. The drug is investigational and has not received FDA approval.

What clinical trials is LHF-535 in?

LHF-535 has been studied in a completed Phase 1 clinical trial with the identifier NCT03993704. This was a multiple ascending oral dose 14-day trial conducted in healthy participants in Australia, enrolling 24 individuals.

Is LHF-535 the same as any other drug?

LHF-535 is a distinct investigational drug candidate developed by TuHURA Biosciences. No alternative names for LHF-535 have been reported in the clinical trial information.