ClinicalTrials.gg
CompletedNCT05152901Updated Jul 24, 2023

Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults

A Phase 1 interventional study of EpiPen ®. and Epinephrine (0.3mg) inhaled in Anaphylactic Reaction, sponsored by De Motu Cordis. Completed at 1 site in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by De Motu Cordis · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Anaphylactic Reaction

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03

In context

Anaphylaxis

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's enrollment of 23 is below the median of 40 across 50 interventional studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

De Motu Cordis is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  1. Male or female and ≥ 18 to ≤ 45 years of age at time of signing the Form.
  2. is between ≥18.00 to 29.00 kg/m2 with a minimum body weight of 45.0 kg.
  3. 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.
  4. Has normal lung function assessed using spirometry and defined by FVC ≥ lower limit of normal (LLN), /FVC ≥ LLN, and PIF ≥ LLN. (FVC- Functional Vital Capacity; FEV- Forced Expiratory Volume)
  5. Has no history of anaphylaxis or severe allergy requiring the use of epinephrine.
  6. 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]).

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Participant has a history of significant or intolerance to lactose.
  3. 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.
  4. Participant has a positive urine drug screen (including cotinine) at Screening and at Baseline (Visit 2/Day -1).
  5. Participant has a positive COVID-19 test at Screening and prior to Baseline (Visit 2/Day -1)
  6. Participant took part a clinical study involving administration of an drug (new chemical entity) in the past 30 days or 5 half-lives prior to Baseline (Visit 2/Day -1).
  7. 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 pill (OCPs) and paracetamol/acetaminophen (1 therapeutic dose [1g] three times per week) at the discretion of the Investigator, and contraceptives.
  8. 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.
  9. 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.
  10. Female participant has a positive urine pregnancy test prior to dosing with IP at Visit 2, Visit, 3, and Visit 4.
  11. Participant has a positive test for , surface antigen (HBsAg), or virus antibody (anti-HCV) with HCV RNA detected at Screening or Day 1 and hepatitis B core antibody (HBcAb) at Screening only.
  12. 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.
  13. Participant has received any of the following vaccinations:

    1. (s) within 1 month prior to Screening or plans to receive such vaccines during the study.
    2. Killed vaccine 1 week prior to Screening.
    3. COVID-19 vaccine Day -7 through to Visit 4.
  14. Participant had surgery of the nose/paranasal sinuses/mouth/throat within 8 weeks prior to Screening.
  15. Participant has any 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.
Terms in these criteria, in plain language(11)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

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.

05

Study design

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

Study arms

  • Active comparator
    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.

    Drug: EpiPen ®.

  • Experimental
    Epinephrine (0.3mg)

    Dosage Form- Inhaled, Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via inhalation on day 2 of Visit 2.

    Drug: Epinephrine (0.3mg) inhaled

  • Experimental
    Epinephrine (1.3mg)

    Dosage Form- Inhaled, Dosage- 1.3mg, Dosage Frequency and Duration- Single dose of 1.3mg epinephrine via inhalation on Visit 3.

    Drug: Epinephrine (1.3mg)

  • Experimental
    Epinephrine (4mg)

    Dosage Form- Inhaled, Dosage-4mg, Dosage Frequency and Duration- Single dose of 4mg epinephrine via inhalation on Visit 4.

    Drug: Epinephrine (4mg)

Interventions

  • DrugEpiPen ®.

    A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.

  • DrugEpinephrine (0.3mg) inhaled

    Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2

  • A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine.

  • A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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)

    Time frame: Screening through to follow up so approx. 66 days

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

    Time frame: Day 1, Day 2, Day16 and Day 30

  4. 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

07

Study locations

1 site
  • Q-Pharm Pty Ltd
    Herston, Queensland 4006, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05152901
Lead sponsor
De Motu Cordis
Collaborators
Novotech (Australia) Pty Limited
Responsible party
Sponsor
First posted
Dec 10, 2021
Start date
Jan 6, 2022
Primary completion
Jun 6, 2022
Completion
Jun 6, 2022
Last update
Jul 24, 2023

Study contacts

Peter O'Neill
study director · peter.oneill@demotucordis.co

Oversight

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

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Epinephrine

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