ClinicalTrials.gg
CompletedNCT06013150Updated Aug 20, 2024

Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.

A Phase 1 interventional study of Epinephrine and Placebo 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 2024-08-20.

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a phase 1, randomised, double blind placebo controlled 2-part study to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of inhaled DMC-IH1 (epinephrine) and relative bioavailability and carryover effects of Inhaled (DMC-IH1) and Intramuscular(IM) (EpiPen®) Epinephrine in healthy male and female participants.

Read the detailed description

DMC-IH1 (Investigational product) inhaler is a proprietary single-use capsule based dry powder inhaler designed for oral pulmonary drug delivery in emergency scenarios.

Part 1 will enrol 24 participants into 3 cohorts receiving a single ascending dose.

Study will comprise 3 periods: Screening, Treatment Period and 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 24 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. Is willing to sign an ICF on a voluntary basis and to voluntarily participate in the study, after being able to read the ICF and understand the information contained within, prior to any Screening procedure being undertaken.
  2. Male or female and ≥18 to ≤45 years of age at time of signing the ICF.
  3. Has a of ≥18.00 to ≤30.00 kg/m2, with a minimum body weight of 45.0 kg and a maximum body weight of 120 kg.
  4. Is in good health based on the results of medical and surgical history, physical examination, vital sign measurements, and clinical laboratory evaluations, as assessed by the Investigator (or designee).
  5. Has a resting heart rate of ≥45 and ≤90 beats per minute; systolic blood pressure of ≥90 but ≤130 mmHg and diastolic blood pressure of ≥50 but ≤90 mmHg at Screening (Visit 1) and prior to randomisation on Day -1 (Visit 2).
  6. Has normal lung function assessed using spirometry and defined by forced vital capacity (FVC) ≥ lower limit of normal (LLN), /FVC ≥LLN, and peak inspiratory flow rate ≥ LLN at Screening (Visit 1).
  7. Has no history of anaphylaxis or severe allergy requiring the use of epinephrine.
  8. Is a non-smoker/non-vaping; or social smoker who currently only uses ≤5 cigarettes per month and has used nicotine on ≤5 occasions within 30 days prior to Screening, a negative cotinine test at Visit 2/Day -1, and ability and willingness to refrain from smoking 7 days prior to the first epinephrine dose through the EOS [Part 1: Visit 3].
  9. Has adequate venous access.
  10. Is able to demonstrate correct use of the device using a practice device and follow directions for use.
  11. Able to follow measures as per Protocol.
  12. Ability and willingness to refrain from undertaking any strenuous exercise (including weightlifting) 48 hours prior to each clinic visit.
  13. Ability and willingness to refrain from alcohol and/or drug use from Screening (or at least 1 week prior to dosing) (testing at Day -1 to ensure compliance) until EOS (Part 1: until Visit 3/EOS).

Exclusion criteria

Exclusion Criteria:

  1. Participant who is pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time from screening to the end of study visit (Part 1: through Visit 3/EOS).
  2. Participant has a history of significant or intolerance to lactose and/or epinephrine.
  3. Participant has a history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular (including severe pulmonary haemorrhage), gastrointestinal, neurological (including history of migraine requiring specific treatment), 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 at Screening and at Baseline (Visit 2/Day -1).
  5. Participant has a positive urine cotinine test at Baseline (Visit 2/Day -1).
  6. Participant took part in 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 randomization (Day -1) through EOS (Part 1: Visit 3/EOS), with the exception of paracetamol/acetaminophen at the discretion of the Investigator, and .
  8. Participant has a history of alcoholism or 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 Screening (Visit 1) and randomization (Day -1/Visit 2).
  9. Participant has a positive alcohol breath test at Screening and prior to randomization (Day -1/Visit 2).
  10. Female participant has a positive serum pregnancy test at Screening and a positive urine pregnancy test prior to randomization (Day -1/Visit 2).
  11. Participant has a positive test for (HIV), surface antigen, or virus antibody (anti-HCV) with HCV RNA detected at Screening and hepatitis B core antibody at Screening.
  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 randomization (Day -1/Visit 2).
    3. COVID-19 vaccine Day -7 through Visit 3 for Part 1.
  14. Participant had surgery of the nose/paranasal sinuses/mouth/throat within 8 weeks or thoracic surgery within 24 weeks prior to Screening or randomization (Day -1/Visit 2).
  15. Participant has any history of respiratory (especially with reduction of respiratory capacity) or history of clinically significant cardiovascular abnormality (eg, including hypertension, ischemic heart disease, previous myocardial infarct, heart failure or conduction abnormalities (SVT, AF, interventricular conduction blocks, etc.) or any other abnormality that in the opinion of the Investigator may pose a safety risk to a participant), 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.
  16. Participant has any of the following criteria:

    1. PR interval >220 ms or \<120 ms
    2. QRS interval >120 ms
    3. interval >450 ms (males) or >470 ms (females)
    4. A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 ms)
    5. ST segment elevation or depression considered to be clinically significant by the PI or designee
    6. T-wave or U-wave abnormalities considered to be clinically significant by the PI or designee -
Terms in these criteria, in plain language(12)

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.

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.

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.

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.

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.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Epinephrine

    Dosage Level: Part 1 of the study: Participants across cohort 1 to 3 will receive a single dose of either 1mg or 1.3mg or 1.5mg respectively of epinephrine or placebo via DMC-IHI device. Dosage form: Single-use capsule based dry powder inhaler Route of administration: Inhalation

    Drug: Epinephrine · Drug: Placebo

  • Placebo comparator
    Placebo

    Drug: Placebo Participants will receive matching placebo across the study.

    Drug: Epinephrine · Drug: Placebo

Interventions

  • Participants in Part 1 of the study will receive single dose either 1mg, 1.3mg or 1.5mg of an inhaled single dose of Epinephrine or placebo delivered via DMC-IHI device.

  • DrugPlacebo

    Participant in Part 1 of the study will receive matching doses of placebo

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Upto 7 days for Part 1

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Upto 7 days for Part 1

  3. Number of participants with changes in the 12-lead electrocardiogram (ECG)

    Time frame: Upto 7 days for Part 1

  4. PK Parameters: Assess timepoints of carryover effect of repeated dose of inhaled epinephrine

    Time frame: Part 1: Pre-dose and multiple timepoints post dose on Day 1.

Secondary outcomes

  1. PK Parameters: Time for maximum concentration (Tmax)

    Time frame: Part 1: Pre-dose multiple timepoints post-dose on Day 1.

  2. PK Parameters: Maximum concentration (Cmax)

    Time frame: Part 1: Pre-dose multiple timepoints post-dose on Day 1.

  3. PK Parameters: Area under Curve (AUC)

    Time frame: Part 1: Pre-dose multiple timepoints post-dose on Day 1.

  4. PD parameters: Maximum effect on heart rate and blood pressure (Emax)

    Time frame: Part 1: 240 minutes postdose.

  5. PD parameters: Time to maximum effect (TEmax)

    Time frame: Part 1: 240 minutes postdose.

07

Study locations

1 site
  • CMAX Clinical Research
    Adelaide, South Australia 5000, 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 reached

Ran from Oct 2023 to primary completion in Dec 2023, 1 month.

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

Registered
Aug 22, 2023
First posted
Aug 28, 2023
StartActual
Oct 24, 2023
Primary completionActual
Dec 15, 2023
CompletionActual
Jul 10, 2024
Last update
Aug 20, 2024
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 Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06013150
Lead sponsor
De Motu Cordis
Collaborators
Novotech (Australia) Pty Limited
Responsible party
Sponsor
First posted
Aug 28, 2023
Start date
Oct 24, 2023
Primary completion
Dec 15, 2023
Completion
Jul 10, 2024
Last update
Aug 20, 2024

Study contacts

Peter O'Neil
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 Aug 2024. 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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