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Epinephrine Product

Phase 1

Anaphylaxis | Small molecule | Immunology |Nasus Pharma Ltd.|Last Updated: Jan 5, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Epinephrine Product · 1 trial · 1 indication

Phase 1 1
NCT04696822Bioavailability of Nasal EpinephrineAnaphylaxis
COMPLETED12 Analytics
PHASE1COMPLETED
Bioavailability of Nasal Epinephrine
AnaphylaxisUnlock trial analytics

Study Endpoints

Primary Endpoints

Epinephrine in blood - Cmax
-1 hour to 8 hours post-dose

pharmacokinetic analysis

Epinephrine in blood- Tmax
-1 hour to 8 hours post-dose

pharmacokinetic analysis

Epinephrine in blood- AUC
-1 hour to 8 hours post-dose

pharmacokinetic analysis

Epinephrine in blood- T half
-1 hour to 8 hours post-dose

pharmacokinetic analysis

Secondary Endpoints

body temperature
morning
Hemoglobin level in blood
at check-in morning
blood hematocrit
check-in morning
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Adults with seasonal allergic rhinitisEXPERIMENTALSingle administration of 1.6mg or 3.2 mg Epinephrine powder nasal spray, with or without allergenic challenge, and single IM 0.3 mg Epinephrine without allergenic challenge.

Interventions

NameTypeDescription
Epinephrine Nasal Product, 1.6 mgDRUGSingle dose Nasal powder spray without allergen challenge
Epinephrine nasal product, 1.6 mg + allergenDRUGSingle dose Nasal powder spray with allergen challenge
Epinephrine Injection 0.3 mgDRUGIntramuscular injection
Epinephrine Nasal Product, 3.2 mgDRUGTwice dose Nasal powder spray without allergen challenge
Epinephrine Nasal Product, 3.2 mg + allergenDRUGTwice dose Nasal powder spray with allergen challenge
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The following inclusion criteria will be assessed at screening (within 28 days prior to the first drug administration): 1. Non-smoking, male and female subjects from 18 to 55 years of age. 2. Documented Positive skin allergy test during the last year. 3. History of hay fever, s...

Countries:Israel
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Frequently asked questions about Epinephrine Product

What is Epinephrine Product used for?

Epinephrine Product is an investigational small molecule being developed for the treatment of anaphylaxis, a severe and potentially life-threatening allergic reaction. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Epinephrine Product?

Epinephrine Product is being developed by Nasus Pharma Ltd., a biopharmaceutical company. The company's stock is traded under the ticker symbol NSRX.

What phase is Epinephrine Product in?

Epinephrine Product is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use. The drug is being studied for the treatment of anaphylaxis.

What clinical trials is Epinephrine Product in?

Epinephrine Product has one completed Phase 1 clinical trial, identified as NCT04696822, titled 'Bioavailability of Nasal Epinephrine'. This trial enrolled 12 participants in Israel and evaluated the drug in healthy volunteers.

Is Epinephrine Product FDA approved?

Epinephrine Product is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of anaphylaxis. The drug has not yet completed the clinical trials required for regulatory approval.