Anaphylactic ReactionPhase 1NCT05152901
Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
A Phase 1 study testing EpiPen ®., Epinephrine (0.3mg) inhaled and Epinephrine (1.3mg) in people with Anaphylactic Reaction, run by De Motu Cordis at 1 site in Australia.
Trial summary
This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylactic Reaction
- What is being tested?
- EpiPen ®., Epinephrine (0.3mg) inhaled and Epinephrine (1.3mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Jan 2022to 6 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female and ≥ 18 to ≤ 45 years of age at time of signing the Informed Consent Form.
- BMI is between ≥18.00 to 29.00 kg/m2 with a minimum body weight of 45.0 kg.
- Participant who is in good health based on the results of medical history, physical examination, vital sign measurements, and clinical laboratory evaluations, as assessed by the Investigator (or designee) with a resting heart rate of ≤ 90 beats per minute and systolic blood pressure of ≤ 130/90 mmHg and diastolic blood pressure of ≤ 90/50 mmHg.
- Has normal lung function assessed using spirometry and defined by FVC ≥ lower limit of normal (LLN), FEV1/FVC ≥ LLN, and PIF ≥ LLN. (FVC- Functional Vital Capacity; FEV- Forced Expiratory Volume)
- Has no history of anaphylaxis or severe allergy requiring the use of epinephrine.
- Who is a non-smoker; or social smoker who only used nicotine on ≤ 5 occasions within 30 days prior to Screening, a negative cotinine test at Screening, and ability and willingness to refrain from tobacco products for the duration of the study (from 7 days prior to the first dose through to EOS [Visit 5]).
Who cannot join
- Participant who is pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study (through Visit 5/EOS).
- Participant has a history of significant hypersensitivity or intolerance to lactose.
- Participant has a history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee) except for fully resolved childhood asthma.
- Participant has a positive urine drug screen (including cotinine) at Screening and at Baseline (Visit 2/Day -1).
- Participant has a positive COVID-19 test at Screening and prior to Baseline (Visit 2/Day -1)
- Participant took part a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to Baseline (Visit 2/Day -1).
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- Participant used or intends to use any prescription or non-prescription medications/products within 14 days prior to dosing through to Follow-up (Visit 5), with the exception of Oral contraceptive pill (OCPs) and paracetamol/acetaminophen (1 therapeutic dose [1g] three times per week) at the discretion of the Investigator, and contraceptives.
- Participant has a history of alcoholism, substance or drug abuse-related disorders deemed significant by the Investigator (or designee) (ie, > 14 drinks/week for women or > 21 drinks/week for men [1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor]) within the last 3 months prior to dosing, must not have consumed more than 14 drinks per week in any week or have a history of alcohol abuse within the last 12 months.
- Participant has a positive alcohol breath test at Screening and prior to dosing with Investigational Product (IP) at Visit 2, Visit 3, and Visit 4.
- Female participant has a positive urine pregnancy test prior to dosing with IP at Visit 2, Visit, 3, and Visit 4.
- Participant has a positive test for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) with HCV RNA detected at Screening or Day 1 and hepatitis B core antibody (HBcAb) at Screening only.
- Participant has presence of any physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
- Participant has received any of the following vaccinations:
- Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the study.
- Killed vaccine 1 week prior to Screening.
- COVID-19 vaccine Day -7 through to Visit 4.
- Participant had surgery of the nose/paranasal sinuses/mouth/throat within 8 weeks prior to Screening.
- Participant has any clinically relevant respiratory (especially with reduction of respiratory capacity) or cardiovascular abnormality (eg, high blood pressure, myocardial infarction in previous 3 months, etc), or any other abnormality that in the opinion of the Investigator may pose a safety risk to a participant in this study, may confound the clinical performance or safety assessment, or may interfere with study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.
Read the detailed description
DMC-IH1 (Investigational Product) is a capsule containing epinephrine bitartrate dry powder blend contained within a single-use, proprietary inhalation device.
The planned dosages for inhalation are 0.3 mg on Visit 2, 1.3 mg (dose will not exceed 6 mg) on Visit 3, and 4 mg (dose will not exceed 6 mg) on Visit 4.
The study will comprise 3 periods: Screening, Treatment, and Follow-up. Total duration of the study is approximately 66 days including -28 days from screening to visit to follow up
- Conditions
- Anaphylactic Reaction
- Being tested
- EpiPen ®., Epinephrine (0.3mg) inhaled, Epinephrine (1.3mg), Epinephrine (4mg)
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiPen ®.Drug
A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.
Epinephrine (0.3mg) inhaledDrug
Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2
Epinephrine (1.3mg)Drug
A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine.
Epinephrine (4mg)Drug
A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine
| Study group | Role | What they receive |
|---|---|---|
| EpiPen ®. | Active comparator | Dosage Form- Intra muscularly (IM), Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via IM on day, Visit 2. Receives: Drug: EpiPen ®. |
| Epinephrine (0.3mg) | Experimental | Dosage Form- Inhaled, Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via inhalation on day 2 of Visit 2. Receives: Drug: Epinephrine (0.3mg) inhaled |
| Epinephrine (1.3mg) | Experimental | Dosage Form- Inhaled, Dosage- 1.3mg, Dosage Frequency and Duration- Single dose of 1.3mg epinephrine via inhalation on Visit 3. Receives: Drug: Epinephrine (1.3mg) |
| Epinephrine (4mg) | Experimental | Dosage Form- Inhaled, Dosage-4mg, Dosage Frequency and Duration- Single dose of 4mg epinephrine via inhalation on Visit 4. Receives: Drug: Epinephrine (4mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by Regulatory Activities (MedDRA) Version 22.0 or higher.
Measured: Screening through to follow up so approx. 66 days
Safety and tolerability of inhaled epinephrine in healthy participants measured through percentage of subjects with abnormal and clinically significant abnormal hematology values.
Measured: Screening through to follow up so approx. 66 days
Safety and tolerability of inhaled epinephrine in healthy participants measured through PR interval in ECG Assessment.
PR interval is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization)
Measured: Screening through to follow up so approx. 66 days
Change in Baseline of heart rate will be monitored from 15 minutes prior to each dosing (to establish baseline) through safety continuous cardiac monitoring (Telemetry) at timepoints to match the pharmacokinetic blood draws.
Measured: Screening through to follow up so approx. 66 days
Safety and tolerability of inhaled epinephrine in healthy participants measured through Functional Vital Capacity (FVC) in the Lung Function test assessment.
Measured: Screening through to follow up so approx. 66 days
Secondary outcomes (4)
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through time to maximum observed epinephrine concentration (Tmax).
Measured: Day 1, Day 2, Day16 and Day 30
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants by plasma concentration-time profiles (Cmax).
Measured: Day 1, Day 2, Day16 and Day 30
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through Area under curve (AUC0-t).
Area under the drug concentration-time curve, from time zero (time of dosing) to the last time point (AUC0-t)
Measured: Day 1, Day 2, Day16 and Day 30
To determine the comparative plasma bioavailability of inhaled epinephrine to intramuscular (IM)epinephrine in healthy participants.
Measured: Day 1, Day 2, Day16 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start6 Jan 2022
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaphylactic ReactionStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- De Motu Cordis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Peter O'Neill, Study director, peter.oneill@demotucordis.co
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152901
- Sponsor's protocol ID
- CTP-00070-00
- Status last verified
- Jul 2023
- First submitted
- 9 Nov 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT05152901
- Acronym / sponsor ID
- CTP-00070-00
- Conditions
- Anaphylactic Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- De Motu CordisIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 10 Dec 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 study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.
Detailed description
DMC-IH1 (Investigational Product) is a capsule containing epinephrine bitartrate dry powder blend contained within a single-use, proprietary inhalation device.
The planned dosages for inhalation are 0.3 mg on Visit 2, 1.3 mg (dose will not exceed 6 mg) on Visit 3, and 4 mg (dose will not exceed 6 mg) on Visit 4.
The study will comprise 3 periods: Screening, Treatment, and Follow-up. Total duration of the study is approximately 66 days including -28 days from screening to visit to follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EpiPen ®. | Active comparator | Drug: EpiPen ®.Dosage Form- Intra muscularly (IM), Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via IM on day, Visit 2. |
| Epinephrine (0.3mg) | Experimental | Drug: Epinephrine (0.3mg) inhaledDosage Form- Inhaled, Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via inhalation on day 2 of Visit 2. |
| Epinephrine (1.3mg) | Experimental | Drug: Epinephrine (1.3mg)Dosage Form- Inhaled, Dosage- 1.3mg, Dosage Frequency and Duration- Single dose of 1.3mg epinephrine via inhalation on Visit 3. |
| Epinephrine (4mg) | Experimental | Drug: Epinephrine (4mg)Dosage Form- Inhaled, Dosage-4mg, Dosage Frequency and Duration- Single dose of 4mg epinephrine via inhalation on Visit 4. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female and ≥ 18 to ≤ 45 years of age at time of signing the Informed Consent Form.
- BMI is between ≥18.00 to 29.00 kg/m2 with a minimum body weight of 45.0 kg.
- Participant who is in good health based on the results of medical history, physical examination, vital sign measurements, and clinical laboratory evaluations, as assessed by the Investigator (or designee) with a resting heart rate of ≤ 90 beats per minute and systolic blood pressure of ≤ 130/90 mmHg and diastolic blood pressure of ≤ 90/50 mmHg.
- Has normal lung function assessed using spirometry and defined by FVC ≥ lower limit of normal (LLN), FEV1/FVC ≥ LLN, and PIF ≥ LLN. (FVC- Functional Vital Capacity; FEV- Forced Expiratory Volume)
- Has no history of anaphylaxis or severe allergy requiring the use of epinephrine.
Key exclusion criteria (18 listed)
- Participant who is pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study (through Visit 5/EOS).
- Participant has a history of significant hypersensitivity or intolerance to lactose.
- Participant has a history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee) except for fully resolved childhood asthma.
- Participant has a positive urine drug screen (including cotinine) at Screening and at Baseline (Visit 2/Day -1).
- Participant has a positive COVID-19 test at Screening and prior to Baseline (Visit 2/Day -1)
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 |
|---|---|---|
| EpiPen ®.A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2. | Drug | EpiPen ®. |
| Epinephrine (0.3mg) inhaledParticipants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2 | Drug | Epinephrine (0.3mg) |
| Epinephrine (1.3mg)A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine. | Drug | Epinephrine (1.3mg) |
| Epinephrine (4mg)A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine | Drug | Epinephrine (4mg) |
Primary outcome
Number of participants with treatment-related adverse events as assessed by Regulatory Activities (MedDRA) Version 22.0 or higher.
Time frame: Screening through to follow up so approx. 66 days
Safety and tolerability of inhaled epinephrine in healthy participants measured through percentage of subjects with abnormal and clinically significant abnormal hematology values.
Time frame: Screening through to follow up so approx. 66 days
Safety and tolerability of inhaled epinephrine in healthy participants measured through PR interval in ECG Assessment.
Time frame: Screening through to follow up so approx. 66 days
PR interval is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization)
Change in Baseline of heart rate will be monitored from 15 minutes prior to each dosing (to establish baseline) through safety continuous cardiac monitoring (Telemetry) at timepoints to match the pharmacokinetic blood draws.
Time frame: Screening through to follow up so approx. 66 days
Safety and tolerability of inhaled epinephrine in healthy participants measured through Functional Vital Capacity (FVC) in the Lung Function test assessment.
Time frame: Screening through to follow up so approx. 66 days
4 secondary outcomes
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through time to maximum observed epinephrine concentration (Tmax).
Time frame: Day 1, Day 2, Day16 and Day 30
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants by plasma concentration-time profiles (Cmax).
Time frame: Day 1, Day 2, Day16 and Day 30
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through Area under curve (AUC0-t).
Time frame: Day 1, Day 2, Day16 and Day 30
To determine the comparative plasma bioavailability of inhaled epinephrine to intramuscular (IM)epinephrine in healthy participants.
Time frame: Day 1, Day 2, Day16 and Day 30
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 24 Jul 2023.
- 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.
Peter O'Neill study director
peter.oneill@demotucordis.co
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 EpiPen ®., Epinephrine (0.3mg) inhaled and Epinephrine (1.3mg) in people with Anaphylactic Reaction, run by De Motu Cordis 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 6 inclusion and 18 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 24 Jul 2023. 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?
Number of participants with treatment-related adverse events as assessed by Regulatory Activities (MedDRA) Version 22.0 or higher. (time frame: Screening through to follow up so approx. 66 days). The study lists 5 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 24 Jul 2023.