Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection

A Two-Treatment, Sequential, Crossover Study of the Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection (Infectious Rhinitis)

This is a Phase 1, single-dose, two-period study that will consist of a combined screening and baseline period and an open-label treatment period. Subjects will be enrolled when they experience an Upper Respiratory Tract Infection with nasal congestion and edema.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infection
• Intervention / Treatment: Drug: ARS-1 with URTI; Drug: ARS-1 without URTI

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Brookvale, New South Wales, Australia, 2100
      • Anthony McGirr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 index between 18 and 32 kg/m2, inclusive.
• Has no declared medical history of hypertension and cardiovascular disease in the last 10 years.

• At screening, has stable vital signs in the following ranges (after 5 minutes of rest):

  • SBP ≥90 and ≤140 mmHg
  • DBP ≥50 and ≤90 mmHg
  • HR ≥45 and ≤100 beats per minute (bpm)
• Is a nonsmoker within the previous 2 months (calculated from first dosing) and does not use tobacco-containing products.

Exclusion Criteria:

• Has a stated history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Has current or past history of clinically significant asthma or angioedema.
• Has prior nasal fractures, severe nasal injuries or history of nasal disorders that could interfere with nasal spray administration.
• Has any clinically significant medical condition or physical exam (PE) finding as deemed inappropriate by the Investigator.
• Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
• Subject reports they have had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.
• Subject reports they have donated blood including platelets or plasma only or had an acute loss of blood (>50 mL) during the 30 days before study drug administration or intends to donate blood or blood products within 30 days after the completion of the study.
• Has a history (within 12 months before screening) of drug use, or has a positive test for drugs of abuse at screening or upon admittance to the study center, or has a stated history of alcohol abuse.

• Has been on an abnormal diet during the four (4) weeks from Day 0. 10. Has participated in a clinical trial within 30 days prior to the first dose of study drug.

  11. Has had treatment with any adrenaline or noradrenaline containing products within 7 days of Day 0.

  12. Has inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARS-1 with URTI	Drug: ARS-1 with URTI; ARS-1; Other Names: Adrenaline
Experimental: ARS-1 without URTI	Drug: ARS-1 without URTI; ARS-1 without URTI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the bioavailability (Cmax) of ARS-1 after intranasal administration	Blood samples will be collected to measure plasma concentrations of adrenaline	Day -1 to Day 30
To evaluate the bioavailability (AUC0-t) of ARS-1 after intranasal administration	Blood samples will be collected to measure plasma concentrations of adrenaline	Day -1 to Day 30
To evaluate the bioavailability (tmax) of ARS-1 after intranasal administration	Blood samples will be collected to measure plasma concentrations of adrenaline	Day -1 to Day 30

Collaborators and Investigators

• Sponsor: ARS Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Anthony McGirr, MD, Northern Beach Clinical Research Pty Ltd,

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine
• Other Study ID Numbers: EPI 014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No