Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EpiPen · 1 trial · 1 indication
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)
| Arm | Type | Description |
|---|---|---|
| EpiPen ®. | ACTIVE_COMPARATOR | Dosage Form- Intra muscularly (IM), Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via IM on day, Visit 2. |
| Epinephrine (0.3mg) | EXPERIMENTAL | Dosage Form- Inhaled, Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via inhalation on day 2 of Visit 2. |
| Epinephrine (1.3mg) | EXPERIMENTAL | Dosage Form- Inhaled, Dosage- 1.3mg, Dosage Frequency and Duration- Single dose of 1.3mg epinephrine via inhalation on Visit 3. |
| Epinephrine (4mg) | EXPERIMENTAL | Dosage Form- Inhaled, Dosage-4mg, Dosage Frequency and Duration- Single dose of 4mg epinephrine via inhalation on Visit 4. |
| Name | Type | Description |
|---|---|---|
| EpiPen ®. | DRUG | A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2. |
| Epinephrine (0.3mg) inhaled | DRUG | Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2 |
| Epinephrine (1.3mg) | DRUG | A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine. |
| Epinephrine (4mg) | DRUG | A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine |
Inclusion Criteria: 1. Male or female and ≥ 18 to ≤ 45 years of age at time of signing the Informed Consent Form. 2. BMI 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 ...
EpiPen is used for anaphylactic reaction, a severe and potentially life-threatening allergic response. It is being studied as a treatment for this condition. The drug is currently in clinical development and is not yet approved for use.
EpiPen is being developed by Cardinal Health, Inc., which is publicly traded under the ticker symbol CAH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating anaphylactic reactions.
EpiPen is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
EpiPen has one completed Phase 1 clinical trial, NCT05152901, which studied inhaled epinephrine and intramuscular epinephrine in healthy adults. The trial enrolled 23 participants in Australia and was active-controlled, meaning it compared the drug against an active comparator.
EpiPen is a brand name for a drug containing epinephrine, also known as adrenaline. The clinical trial NCT05152901 studied both inhaled and intramuscular forms of epinephrine. The drug is being developed as a small molecule for the treatment of anaphylactic reactions.