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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04930900




Registration number
NCT04930900
Ethics application status
Date submitted
9/06/2021
Date registered
18/06/2021
Date last updated
29/07/2022

Titles & IDs
Public title
Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection
Scientific title
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)
Secondary ID [1] 0 0
EPI 014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Respiratory Tract Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARS-1 with URTI
Treatment: Drugs - ARS-1 without URTI

Experimental: ARS-1 with URTI - ARS-1 with URTI

Experimental: ARS-1 without URTI - ARS-1 without URTI


Treatment: Drugs: ARS-1 with URTI
ARS-1

Treatment: Drugs: ARS-1 without URTI
ARS-1 without URTI
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the bioavailability (Cmax) of ARS-1 after intranasal administration
Timepoint [1] 0 0
Day -1 to Day 30
Primary outcome [2] 0 0
To evaluate the bioavailability (AUC0-t) of ARS-1 after intranasal administration
Timepoint [2] 0 0
Day -1 to Day 30
Primary outcome [3] 0 0
To evaluate the bioavailability (tmax) of ARS-1 after intranasal administration
Timepoint [3] 0 0
Day -1 to Day 30

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/07/2022
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Anthony McGirr - Brookvale
Recruitment postcode(s) [1] 0 0
2100 - Brookvale

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ARS Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04930900
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony McGirr, MD
Address 0 0
Northern Beach Clinical Research Pty Ltd,
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04930900