Anaphylactic ReactionPhase 1NCT06013150
Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.
A Phase 1 study testing Epinephrine in people with Anaphylactic Reaction, run by De Motu Cordis at 1 site in Australia.
Trial 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… 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?
- Epinephrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Oct 2023to 10 Jul 2024
- 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
- 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.
- Male or female and ≥18 to ≤45 years of age at time of signing the ICF.
- Has a BMI 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.
- 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).
- 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).
- Has normal lung function assessed using spirometry and defined by forced vital capacity (FVC) ≥ lower limit of normal (LLN), forced expiratory volume in 1 second/FVC ≥LLN, and peak inspiratory flow rate ≥ LLN at Screening (Visit 1).
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- Has no history of anaphylaxis or severe allergy requiring the use of epinephrine.
- 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].
- Has adequate venous access.
- Is able to demonstrate correct use of the device using a practice device and follow directions for use.
- Able to follow contraceptive measures as per Protocol.
- Ability and willingness to refrain from undertaking any strenuous exercise (including weightlifting) 48 hours prior to each clinic visit.
- 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).
Who cannot join
- 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).
- Participant has a history of significant hypersensitivity or intolerance to lactose and/or epinephrine.
- 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.
- Participant has a positive urine drug screen at Screening and at Baseline (Visit 2/Day -1).
- Participant has a positive urine cotinine test at Baseline (Visit 2/Day -1).
- Participant took part in 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 randomization (Day -1) through EOS (Part 1: Visit 3/EOS), with the exception of paracetamol/acetaminophen at the discretion of the Investigator, and contraceptives.
- 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).
- Participant has a positive alcohol breath test at Screening and prior to randomization (Day -1/Visit 2).
- Female participant has a positive serum pregnancy test at Screening and a positive urine pregnancy test prior to randomization (Day -1/Visit 2).
- Participant has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus antibody (anti-HCV) with HCV RNA detected at Screening and hepatitis B core antibody at Screening.
- 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 randomization (Day -1/Visit 2).
- COVID-19 vaccine Day -7 through Visit 3 for Part 1.
- 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).
- Participant has any history of clinically relevant 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.
- Participant has any of the following ECG criteria:
- PR interval >220 ms or <120 ms
- QRS interval >120 ms
- QTcF interval >450 ms (males) or >470 ms (females)
- A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 ms)
- ST segment elevation or depression considered to be clinically significant by the PI or designee
- T-wave or U-wave abnormalities considered to be clinically significant by the PI or designee -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Part Study in Healthy Male and Female Participants; Part 1 - A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose-Escalation Study of Inhaled DMC-IH1; Part 2 - An Open-Label, 3-Arm Study Assessing the Carryover Effects of Inhaled (DMC-IH1) and Intramuscular (EpiPen®) Epinephrine
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.
- Conditions
- Anaphylactic Reaction
- Being tested
- Epinephrine, Placebo
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
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.
PlaceboDrug
Participant in Part 1 of the study will receive matching doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine | Experimental | 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 Receives: Drug: Epinephrine; Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo
Participants will receive matching placebo across the study. Receives: Drug: Epinephrine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Upto 7 days for Part 1
Number of participants with clinical laboratory abnormalities
Measured: Upto 7 days for Part 1
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Measured: Upto 7 days for Part 1
PK Parameters: Assess timepoints of carryover effect of repeated dose of inhaled epinephrine
Measured: Part 1: Pre-dose and multiple timepoints post dose on Day 1.
Secondary outcomes (5)
PK Parameters: Time for maximum concentration (Tmax)
Measured: Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PK Parameters: Maximum concentration (Cmax)
Measured: Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PK Parameters: Area under Curve (AUC)
Measured: Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PD parameters: Maximum effect on heart rate and blood pressure (Emax)
Measured: Part 1: 240 minutes postdose.
PD parameters: Time to maximum effect (TEmax)
Measured: Part 1: 240 minutes postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start24 Oct 2023
- Primary completion15 Dec 2023
- Study completion10 Jul 2024
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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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'Neil, Study director, peter.oneill@demotucordis.co
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013150
- Sponsor's protocol ID
- DMC-CL-002
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2023
- Last updated
- 20 Aug 2024
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part Study in Healthy Male and Female Participants; Part 1 - A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose-Escalation Study of Inhaled DMC-IH1; Part 2 - An Open-Label, 3-Arm Study Assessing the Carryover Effects of Inhaled (DMC-IH1) and Intramuscular (EpiPen®) Epinephrine
- ClinicalTrials.gov ID
- NCT06013150
- Acronym / sponsor ID
- DMC-CL-002
- Conditions
- Anaphylactic Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- De Motu CordisIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 28 Aug 2023 (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, 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine | Experimental | Drug: Epinephrine, Drug: PlaceboDosage 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 |
| Placebo | Placebo comparator | Drug: Epinephrine, Drug: PlaceboDrug: Placebo Participants will receive matching placebo across the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
- Male or female and ≥18 to ≤45 years of age at time of signing the ICF.
- Has a BMI 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.
- 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).
- 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).
Key exclusion criteria (25 listed)
- 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).
- Participant has a history of significant hypersensitivity or intolerance to lactose and/or epinephrine.
- 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.
- Participant has a positive urine drug screen at Screening and at Baseline (Visit 2/Day -1).
- Participant has a positive urine cotinine test at 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 |
|---|---|---|
| EpinephrineParticipants 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. | Drug | Epinephrine, Placebo |
| PlaceboParticipant in Part 1 of the study will receive matching doses of placebo | Drug | Epinephrine, Placebo |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Upto 7 days for Part 1
Number of participants with clinical laboratory abnormalities
Time frame: Upto 7 days for Part 1
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Time frame: Upto 7 days for Part 1
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.
5 secondary outcomes
PK Parameters: Time for maximum concentration (Tmax)
Time frame: Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PK Parameters: Maximum concentration (Cmax)
Time frame: Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PK Parameters: Area under Curve (AUC)
Time frame: Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PD parameters: Maximum effect on heart rate and blood pressure (Emax)
Time frame: Part 1: 240 minutes postdose.
PD parameters: Time to maximum effect (TEmax)
Time frame: Part 1: 240 minutes postdose.
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 20 Aug 2024.
- 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'Neil 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 Epinephrine 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 13 inclusion and 25 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 20 Aug 2024. 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. Some participants in this study may receive a placebo. 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 adverse events (AEs) (time frame: Upto 7 days for Part 1). The study lists 4 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 20 Aug 2024.