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PN-232

Phase 1

Undisclosed | Small molecule | Other |Protagonist Therapeutics, Inc.|Trials Updated: Oct 3, 2022

PN-232 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2021

PN-232 target and mechanism

Molecular targetIL-23 receptor
Target classReceptor
ModalitySmall molecule

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

PN-232 clinical trials

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
Healthy SubjectsUnlock trial analytics

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?

PN-232 is an investigational small molecule developed by Protagonist Therapeutics, Inc. (NASDAQ: PTGX). It is designed to target the IL-23 receptor and has been studied in a Phase 1 clinical trial in healthy volunteers. The specific therapeutic indications for PN-232 have not been disclosed.

What does PN-232 target?

PN-232 targets the IL-23 receptor. By binding to this receptor, it is intended to modulate IL-23 signaling, a pathway involved in inflammatory responses. The drug is a small molecule and is being developed by Protagonist Therapeutics.

Who is developing PN-232?

PN-232 is being developed by Protagonist Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PTGX. The company is responsible for the clinical development of PN-232.

What phase is PN-232 in?

PN-232 is in Phase 1 clinical development. A Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.

What clinical trials is PN-232 in?

PN-232 has been evaluated in a Phase 1 clinical trial, NCT04819620, titled "Pharmacokinetics of PN-232 in Healthy Volunteers." This completed trial enrolled 48 healthy adult participants in Australia and used a randomized, double-blind, controlled design.