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CompletedNCT04930900Updated Jul 29, 2022

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

A Phase 1 interventional study of ARS-1 with URTI and ARS-1 without URTI in Upper Respiratory Tract Infection, sponsored by ARS Pharmaceuticals, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by ARS Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2022, 4 years 7 months ago, and no results have been posted to the registry.

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Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 29 studies in Respiratory Tract Infections with a site in Australia — 6 open to participants now, 6 under way, 2 of them phase 3. Respiratory Tract Infections · Australia.

Enrollment
27th of 27
15 · median 189
Started
2021
with 1 other
Phase 1
5 of 29
none open now
Registered
18th of 29
by date
Lead sponsor
1 of 29
ARS Pharmaceuticals, Inc.

Among the 29 studies in Respiratory Tract Infections with a site in Australia, this one is the 27th largest by enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2021, is one of 5 in phase 1, and was the 18th registered.

Respiratory Tract Infections

753 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.

Browse Respiratory Tract Infections studies →

Open to participants now

6 of the 29 studies in Respiratory Tract Infections with a site in Australia are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →

Who these studies take

Of the 74 Respiratory Tract Infections studies recruiting now, 35 (47%) set no upper age limit and 31 (42%) stop at 75 or younger; 34 take children under 18; 25 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Upper Respiratory Tract Infection
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Has a stated history of 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 .
  • Subject reports they have had significant traumatic injury, major surgery or open within 30 days prior to study screening.
  • Subject reports they have donated blood including 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.

    1. Has had treatment with any adrenaline or noradrenaline containing products within 7 days of Day 0.
    1. Has inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    ARS-1 with URTI

    ARS-1 with URTI

    Drug: ARS-1 with URTI

  • Experimental
    ARS-1 without URTI

    ARS-1 without URTI

    Drug: ARS-1 without URTI

Interventions

  • DrugARS-1 with URTI

    Drug page: Epinephrine

    ARS-1

    Also known as: Adrenaline

  • DrugARS-1 without URTI

    ARS-1 without URTI

06

What researchers measure

Primary outcomes

  1. To evaluate the bioavailability (Cmax) of ARS-1 after intranasal administration

    Blood samples will be collected to measure plasma concentrations of adrenaline

    Time frame: Day -1 to Day 30

  2. To evaluate the bioavailability (AUC0-t) of ARS-1 after intranasal administration

    Blood samples will be collected to measure plasma concentrations of adrenaline

    Time frame: Day -1 to Day 30

  3. To evaluate the bioavailability (tmax) of ARS-1 after intranasal administration

    Blood samples will be collected to measure plasma concentrations of adrenaline

    Time frame: Day -1 to Day 30

07

Study locations

1 site
  • Anthony McGirr
    Brookvale, New South Wales 2100, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Mar 2022, 7 months.

Of 26 industry-sponsored phase 1 interventional studies under Respiratory Tract Infections, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's 7 months is above that.

Counting every sponsor, half of 35 studies reached it within 8 months; a quarter within 1 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2021
First posted
Jun 18, 2021
StartActual
Aug 9, 2021
Primary completionActual
Mar 31, 2022
CompletionActual
Jul 25, 2022
Last update
Jul 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04930900
Lead sponsor
ARS Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jun 18, 2021
Start date
Aug 9, 2021
Primary completion
Mar 31, 2022
Completion
Jul 25, 2022
Last update
Jul 29, 2022

Study contacts

Anthony McGirr, MD
principal investigator · Northern Beach Clinical Research Pty Ltd,

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Epinephrine

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