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ARS-1 with URTI

Phase 1

Upper Respiratory Tract Infection | Small molecule | Infectious Disease |ARS Pharmaceuticals, Inc.|Last Updated: Jul 29, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

ARS-1 with URTI · 1 trial · 1 indication

Phase 1 1
NCT04930900Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract InfectionUpper Respiratory Tract Infection
COMPLETED15 Analytics
PHASE1COMPLETED
Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection
Upper Respiratory Tract Infection
NCT0493090015
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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 to 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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Frequently asked questions about ARS-1 with URTI

What is ARS-1 used for?

ARS-1 is an investigational small molecule being studied for asthma, urticaria, and upper respiratory tract infection. It is developed by ARS Pharmaceuticals, Inc. (ticker: SPRY). The drug is in clinical development and has not been approved by the FDA.

What does ARS-1 target?

ARS-1 is an intranasal epinephrine formulation. Epinephrine targets adrenergic receptors, which mediate its effects on conditions like asthma and urticaria. The drug is designed to deliver epinephrine through the nasal route for systemic absorption.

Who makes ARS-1?

ARS-1 is developed by ARS Pharmaceuticals, Inc., a biopharmaceutical company traded under the ticker SPRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in respiratory and allergic conditions.

What phase is ARS-1 in?

ARS-1 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, but it remains investigational and is not yet approved by the FDA. The drug is being studied for asthma, urticaria, and upper respiratory tract infection.

What clinical trials is ARS-1 in?

ARS-1 has completed three clinical trials: NCT04930900 (Phase 1, upper respiratory tract infection), NCT05363670 (Phase 2, asthma), and NCT05496465 (Phase 2, urticaria). These trials were conducted in Australia and the United States, with enrollments ranging from 15 to 21 participants.

Is ARS-1 the same as epinephrine?

ARS-1 is an intranasal formulation of epinephrine, also known as adrenaline. It is designed to deliver epinephrine via the nasal route, potentially offering an alternative to injectable forms. The drug is being studied for conditions like asthma and urticaria.