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ALPN-303

Phase 1

Healthy Volunteers | Small molecule | Other |Vertex Pharmaceuticals Incorporated|Last Updated: May 9, 2023

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05034484A Study of ALPN-303 in Adult Healthy VolunteersPHASE1 COMPLETED 72Nov 15, 2021Feb 27, 2023May 9, 20232 Australia
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Study Endpoints
Primary Endpoints
Treatment-emergent Adverse Events (TEAE)
Day 1 through Day 30

Type, incidence, and severity of TEAE as assessed by CTCAE

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
ALPN-303 Regimen AEXPERIMENTAL -
Placebo Regimen APLACEBO_COMPARATOR -
ALPN-303 Regimen BEXPERIMENTAL -
Placebo Regimen BPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ALPN-303DRUGMultiple dose levels will be evaluated.
PlaceboDRUGPlacebo will be administered
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Summary of Inclusion Criteria: * Able and willing to provide written informed consent * Body mass index 18 to 32 kg/m2 * Agree to avoid strenuous physical activity for 2 days prior to each study visit * Agree to use highly effective contraception during the study (all participants) and for 90 days ...

Countries:Australia
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