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PN-232

Phase 1

Healthy Subjects | Small molecule | Other |Protagonist Therapeutics, Inc.|Last Updated: Oct 3, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

PN-232 · 1 trial · 1 indication

Phase 1 1
NCT04819620Pharmacokinetics of PN-232 in Healthy VolunteersHealthy Subjects
COMPLETED48 Analytics
PHASE1COMPLETED
Pharmacokinetics of PN-232 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Safety of PN-232
10 days

Number and Severity of Adverse Events

Secondary Endpoints

Peak concentration of PN-232 in plasma
10 days
Area under the Concentration (AUC) of PN-232
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 administration

Interventions

NameTypeDescription
PN-232DRUGActive Drug
PlaceboDRUGMatching Placebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Key Inclusion Criteria: * Subjects must have BMI between 18 and 32 kg/m2 * 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 * Subjects must be willing to attend required ...

Countries:Australia
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Frequently asked questions about PN-232

What is PN-232 used for?

PN-232 is an investigational small molecule being studied in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics in healthy volunteers. The drug is not approved for any indication and remains in early-stage clinical testing.

Who makes PN-232?

PN-232 is being developed by Protagonist Therapeutics, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker PTGX. The company is conducting clinical research on this investigational small molecule in healthy subjects.

What phase is PN-232 in?

PN-232 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing early-stage clinical evaluation in healthy subjects.

What clinical trials is PN-232 in?

PN-232 has one completed clinical trial, identified as NCT04819620, titled "Pharmacokinetics of PN-232 in Healthy Volunteers." This Phase 1 study enrolled 48 healthy subjects in Australia and was a randomized, double-blind, controlled trial.

Is PN-232 FDA approved?

PN-232 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial was a pharmacokinetic study in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.