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PN-235

Phase 1

Healthy Volunteers | Small molecule | Other |Protagonist Therapeutics, Inc.|Last Updated: Feb 18, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

PN-235 · 1 trial · 1 indication

Phase 1 1
NCT04621630Pharmacokinetics of PN-235 in Healthy VolunteersHealthy Volunteers
COMPLETED107 Analytics
PHASE1COMPLETED
Pharmacokinetics of PN-235 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Safety of PN-235
10 days

Number and severity of Adverse Events

Secondary Endpoints

Pharmacokinetics (PK) of PN-235 in plasma
10 days
Area Under the Concentration (AUC) of PN-235
10 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single DoseEXPERIMENTALSingle dose administration
Multiple DoseEXPERIMENTALMultiple dose administration
Solid Dose ComparisonEXPERIMENTALSolid dose administartion

Interventions

NameTypeDescription
PN-235DRUGActive Drug
PlaceboDRUGMatching Placebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Subjects must have BMI between 18 and 32 * Subjects must be non-smokers or social smokers * Subjects must comply with contraception requirements * Subjects must be willing to consume meals provided by the clinical center Key Exclusion Criteria: * Subject must not have hi...

Countries:Australia
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Frequently asked questions about PN-235

What is PN-235?

PN-235 is an investigational small molecule being developed by Protagonist Therapeutics, Inc. (PTGX). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.

What is PN-235 used for?

PN-235 is being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, and its intended therapeutic indication has not been specified beyond healthy volunteer studies. The drug is an investigational small molecule.

Who makes PN-235?

PN-235 is being developed by Protagonist Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker PTGX. The company is conducting clinical trials to evaluate the drug in healthy volunteers.

What phase is PN-235 in?

PN-235 is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PN-235 in?

PN-235 has been studied in one completed Phase 1 clinical trial, NCT04621630, titled "Pharmacokinetics of PN-235 in Healthy Volunteers." The trial enrolled 107 participants in Australia and was a randomized, double-blind, controlled study.

Is PN-235 the same as any other drug?

PN-235 is a distinct investigational drug developed by Protagonist Therapeutics. No alternative names for PN-235 have been reported in clinical trial registries.