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
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.
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
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 →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.
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.
Exclusion Criteria:
Participant has received any of the following vaccinations:
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.
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.
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.
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.
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.
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.
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.
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 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 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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 ®.
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
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)
Dosage Form- Inhaled, Dosage-4mg, Dosage Frequency and Duration- Single dose of 4mg epinephrine via inhalation on Visit 4.
Drug: Epinephrine (4mg)
A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.
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
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.
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
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
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).
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
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
Plan to share: No
No publications or documents are linked to this record.
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
De Motu Cordis