Upper Respiratory Tract InfectionPhase 1NCT04930900
Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection
A Phase 1 study testing ARS-1 with URTI and ARS-1 without URTI in people with Upper Respiratory Tract Infection, run by ARS Pharmaceuticals, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- ARS-1 with URTI and ARS-1 without URTI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Aug 2021to 25 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
- Being tested
- ARS-1 with URTI, ARS-1 without URTI
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARS-1 with URTIDrug
Also called Adrenaline
ARS-1
ARS-1 without URTIDrug
ARS-1 without URTI
| Study group | Role | What they receive |
|---|---|---|
| ARS-1 with URTI | Experimental | ARS-1 with URTI Receives: Drug: ARS-1 with URTI |
| ARS-1 without URTI | Experimental | ARS-1 without URTI Receives: Drug: ARS-1 without URTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the bioavailability (Cmax) of ARS-1 after intranasal administration
Blood samples will be collected to measure plasma concentrations of adrenaline
Measured: 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
Measured: 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
Measured: Day -1 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start9 Aug 2021
- Primary completion31 Mar 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARS Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony McGirr, MD, Principal investigator, Northern Beach Clinical Research Pty Ltd,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930900
- Sponsor's protocol ID
- EPI 014
- Status last verified
- Jul 2022
- First submitted
- 9 Jun 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04930900
- Acronym / sponsor ID
- EPI 014
- Conditions
- Upper Respiratory Tract Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ARS Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARS-1 with URTI | Experimental | Drug: ARS-1 with URTIARS-1 with URTI |
| ARS-1 without URTI | Experimental | Drug: ARS-1 without URTIARS-1 without URTI |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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):
- Is a nonsmoker within the previous 2 months (calculated from first dosing) and does not use tobacco-containing products.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARS-1 with URTIAlso: AdrenalineARS-1 | Drug | ARS-1 with URTI |
| ARS-1 without URTIARS-1 without URTI | Drug | ARS-1 without URTI |
Primary outcome
To evaluate the bioavailability (Cmax) of ARS-1 after intranasal administration
Time frame: 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
Time frame: 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
Time frame: Day -1 to Day 30
Blood samples will be collected to measure plasma concentrations of adrenaline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony McGirr, MD principal investigator
Northern Beach Clinical Research Pty Ltd,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARS-1 with URTI and ARS-1 without URTI in people with Upper Respiratory Tract Infection, run by ARS Pharmaceuticals, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the bioavailability (Cmax) of ARS-1 after intranasal administration (time frame: Day -1 to Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.