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ARS-1 with URTI

Phase 1

Upper Respiratory Tract Infection | Small molecule | Other |ARS Pharmaceuticals, Inc.|Last Updated: Jul 29, 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
CONTROLLED
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04930900Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract InfectionPHASE1 COMPLETED 15Aug 9, 2021Jul 25, 2022Jul 29, 20221 Australia
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Study Endpoints
Primary Endpoints
To evaluate the bioavailability (Cmax) of ARS-1 after intranasal administration
Day -1 to Day 30

Blood samples will be collected to measure plasma concentrations of adrenaline

To evaluate the bioavailability (AUC0-t) of ARS-1 after intranasal administration
Day -1 to Day 30

Blood samples will be collected to measure plasma concentrations of adrenaline

To evaluate the bioavailability (tmax) of ARS-1 after intranasal administration
Day -1 to Day 30

Blood samples will be collected to measure plasma concentrations of adrenaline

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARS-1 with URTIEXPERIMENTALARS-1 with URTI
ARS-1 without URTIEXPERIMENTALARS-1 without URTI
Interventions
NameTypeDescription
ARS-1 with URTIDRUGARS-1
ARS-1 without URTIDRUGARS-1 without URTI
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Treatment Period 1 only, subject has symptoms of an URTI at time of dosing based on the clinical judgement and the positive infectious cause of URTI to be confirmed by Respiratory Pathogens Panel. * Has body weight more than 55 kg for male and 50 kg for female and body mass in...

Countries:Australia
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