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PN-235

Phase 1

Undisclosed | Small molecule | Other |Protagonist Therapeutics, Inc.|Trials Updated: Feb 18, 2022

PN-235 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2020

PN-235 target and mechanism

Molecular targetIL-23 receptor
Target classReceptor
ModalitySmall molecule

Also known as Active Drug

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

PN-235 clinical trials

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
Healthy VolunteersUnlock trial analytics

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 developed by Protagonist Therapeutics, Inc. It is an orally administered drug candidate that has been studied in Phase 1 clinical testing. Protagonist Therapeutics trades on the Nasdaq under the ticker PTGX.

What does PN-235 target?

PN-235 targets the IL-23 receptor. The IL-23 receptor is a cell surface receptor involved in inflammatory signaling pathways. By binding to this receptor, PN-235 is designed to modulate IL-23 mediated signaling. It is a small molecule therapeutic candidate.

Who is developing PN-235?

PN-235 is being developed by Protagonist Therapeutics, Inc., a biopharmaceutical company listed on the Nasdaq under the ticker symbol PTGX. The company is responsible for the clinical development of this small molecule IL-23 receptor targeting candidate.

What phase is PN-235 in?

PN-235 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in any trials. As an investigational drug, it has not been approved by the FDA for any indication.

What clinical trials is PN-235 in?

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