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Epinephrine

Phase 1

Anaphylactic Reaction | Small molecule | Immunology |Cardinal Health, Inc.|Last Updated: Aug 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Epinephrine · 1 trial · 1 indication

Phase 1 1
NCT06013150Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.Anaphylactic Reaction
COMPLETED24 Analytics
PHASE1COMPLETED
Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.
Anaphylactic ReactionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Upto 7 days for Part 1
Number of participants with clinical laboratory abnormalities
Upto 7 days for Part 1
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Upto 7 days for Part 1
PK Parameters: Assess timepoints of carryover effect of repeated dose of inhaled epinephrine
Part 1: Pre-dose and multiple timepoints post dose on Day 1.

Secondary Endpoints

PK Parameters: Time for maximum concentration (Tmax)
Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PK Parameters: Maximum concentration (Cmax)
Part 1: Pre-dose multiple timepoints post-dose on Day 1.
PK Parameters: Area under Curve (AUC)
Part 1: Pre-dose multiple timepoints post-dose on Day 1.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EpinephrineEXPERIMENTALDosage 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
PlaceboPLACEBO_COMPARATORDrug: Placebo Participants will receive matching placebo across the study.

Interventions

NameTypeDescription
EpinephrineDRUGParticipants 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.
PlaceboDRUGParticipant in Part 1 of the study will receive matching doses of placebo
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ti...

Countries:Australia
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Frequently asked questions about Epinephrine

What is Epinephrine used for in Anaphylactic Reaction?

Epinephrine is used for the treatment of anaphylactic reaction, a severe and potentially life-threatening allergic response. It is being studied as a small molecule therapeutic in the immunology therapeutic area. The drug is currently in Phase 1 clinical development.

Who makes Epinephrine?

Epinephrine is being developed by Cardinal Health, Inc., a company traded on the New York Stock Exchange under the ticker symbol CAH. The company is conducting clinical research on this drug for the treatment of anaphylactic reaction.

What phase is Epinephrine in?

Epinephrine is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for its safety and tolerability in healthy volunteers.

What clinical trials is Epinephrine in?

Epinephrine has one completed clinical trial, identified as NCT06013150. This was a Phase 1 study titled "Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants." The trial enrolled 24 participants in Australia.

Is Epinephrine the same as EpiPen?

Epinephrine is the active ingredient in EpiPen, an auto-injector device. The clinical trial NCT06013150 compared an inhaled formulation of epinephrine (DMC-IH1) with intramuscular EpiPen. The study was conducted in healthy volunteers to evaluate the investigational inhaled version.