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PN-232

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04819620Pharmacokinetics of PN-232 in Healthy VolunteersPHASE1 COMPLETED 48May 13, 2021Jun 16, 2022Oct 3, 20222 Australia
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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 — 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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