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

NCT04930900 | Completed Phase 1 FDA Drug

• 1 other identifier: EPI 014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

ARS-1 with URTI

EXPERIMENTAL

ARS-1 with URTI

Drug: ARS-1 with URTI

ARS-1 without URTI

EXPERIMENTAL

ARS-1 without URTI

Drug: ARS-1 without URTI

Interventions

ARS-1 with URTI DRUG

ARS-1

Also known as: Adrenaline

ARS-1 with URTI

ARS-1 without URTI DRUG

ARS-1 without URTI

ARS-1 without URTI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Has had treatment with any adrenaline or noradrenaline containing products within 7 days of Day 0.
• \. Has inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.

Sponsors & Collaborators

• ARS Pharmaceuticals, Inc.: lead

Study Sites (1)

Anthony McGirr

Brookvale, New South Wales, 2100, Australia

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cold Temperature; Epinephrine

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Anthony McGirr, MD

  Northern Beach Clinical Research Pty Ltd,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 18, 2021
• Study Start: August 9, 2021
• Primary Completion: March 31, 2022
• Study Completion: July 25, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)