Bioavailability of Nasal Epinephrine

NCT04696822 | Completed Phase 1

• 1 other identifier: NP-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder with Epinephrine 0.3 mg Intramuscular Injection in Adult Subjects with Seasonal Allergic Rhinitis with and without Nasal Allergen Challenge

Conditions

Anaphylaxis

Outcome Measures

Primary Outcomes (4)

• Epinephrine in blood - Cmax

  pharmacokinetic analysis

  -1 hour to 8 hours post-dose

• Epinephrine in blood- Tmax

  pharmacokinetic analysis

  -1 hour to 8 hours post-dose

• Epinephrine in blood- AUC

  pharmacokinetic analysis

  -1 hour to 8 hours post-dose

• Epinephrine in blood- T half

  pharmacokinetic analysis

  -1 hour to 8 hours post-dose

Secondary Outcomes (19)

• body temperature

  morning

• Hemoglobin level in blood

  at check-in morning

• blood hematocrit

  check-in morning

• Blood pressure

  Prior to drug administration

• Pulse

  Prior to drug administration

Study Arms (1)

Adults with seasonal allergic rhinitis

EXPERIMENTAL

Single 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.

Drug: Epinephrine Nasal Product, 1.6 mg; Drug: Epinephrine nasal product, 1.6 mg + allergen; Drug: Epinephrine Injection 0.3 mg; Drug: Epinephrine Nasal Product, 3.2 mg; Drug: Epinephrine Nasal Product, 3.2 mg + allergen

Interventions

Epinephrine Nasal Product, 1.6 mg DRUG

Single dose Nasal powder spray without allergen challenge

Also known as: FMXIN002 Microspheres Powder

Adults with seasonal allergic rhinitis

Epinephrine nasal product, 1.6 mg + allergen DRUG

Single dose Nasal powder spray with allergen challenge

Also known as: FMXIN002 Microspheres Powder

Adults with seasonal allergic rhinitis

Epinephrine Injection 0.3 mg DRUG

Intramuscular injection

Also known as: EpiPen

Adults with seasonal allergic rhinitis

Epinephrine Nasal Product, 3.2 mg DRUG

Twice dose Nasal powder spray without allergen challenge

Also known as: FMXIN002 Microspheres Powder, double dose

Adults with seasonal allergic rhinitis

Epinephrine Nasal Product, 3.2 mg + allergen DRUG

Twice dose Nasal powder spray with allergen challenge

Also known as: FMXIN002 Microspheres Powder, double dose

Adults with seasonal allergic rhinitis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking, male and female subjects from 18 to 55 years of age.
• Documented Positive skin allergy test during the last year.
• History of hay fever, seasonal allergies, or rhinitis.
• BMI ≥18 and \<=30 kg/m2.
• Females may be of childbearing or non-childbearing potential:
• Childbearing potential:
• o Physically capable of becoming pregnant
• Non-childbearing potential:
• Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
• Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause.
• Willing to use acceptable, effective methods of contraception.
• Able to tolerate venipuncture.
• Be informed of the nature of the study and give written consent prior to any study procedure.
• Willing and being able to remain in the clinic for the entire duration of the confinement period.
• Have good intravenous access on both arms and hands.

You may not qualify if:

• Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Known or suspected carcinoma. Known history or presence of hypersensitivity or idiosyncratic reaction to epinephrine, sulfite, other excipients of epinephrine auto-injector, or any other drug substances with similar activity.
• Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
• Known history or presence of cardiac arrythmias, coronary artery disease or organic heart disease.
• Known history or presence of hyperthyroidism. Known history or presence of diabetes. Known history or presence of Parkinson's disease. Known history or presence of any food allergy. Presence of hepatic or renal dysfunction. Presence of nostril or septum piercing. Presence of abnormal nasal anatomy (e.g., polyps, unilateral or bilateral abnormalities of the nares, nasal turbinates, or septum including deviated septum).
• History of nasal surgery. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
• History of drug or alcohol addiction requiring treatment or positive alcohol breath test at check-in.
• Any acute illness (e.g. cold, acute infection) which is considered significant by the Investigator and that has not resolved within 7 days before the first drug administration.
• Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
• Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
• Difficulty fasting or consuming standard meals. Inability to communicate well with the Investigators and staff (e.g., language problem, poor mental development or impaired cerebral function).
• Non-cooperative or unwilling to sign consent form or unwilling to attend scheduled clinic visits and/or comply with the study protocol.
• Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
• Females who:
• Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to drug administration;

Sponsors & Collaborators

• Nasus Pharma: lead

Study Sites (1)

Hadassah Medical Center, Ein Kerem

Jerusalem, Israel

Location

Related Publications (1)

• Tal Y, Ribak Y, Rubin L, Talmon A, Shamriz O, Hershko AY, Blotnick S, Bouhajib M, Krayz GT, Abrutzky C, Megiddo D, Lapidot T, Caraco Y. Fast Acting, Dry Powder, Needle-Free, Intranasal Epinephrine Spray: A Promising Future Treatment for Anaphylaxis. J Allergy Clin Immunol Pract. 2023 Oct;11(10):3047-3054. doi: 10.1016/j.jaip.2023.06.044. Epub 2023 Jun 30.

  PMID: 37394178 RESULT

Related Links

• full text open article

MeSH Terms

Conditions

Anaphylaxis

Interventions

Allergens; Epinephrine

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Yoseph Caraco, Prof.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single-dose, two-period, three-treatment, fixed-sequence, comparative bioavailability study

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: January 6, 2021
• Study Start: November 1, 2020
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: January 5, 2024

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)