Comparative Bioavailability of Intranasal Epinephrine

NCT06205134 | Completed Phase 1 DMC

• 1 other identifier: NP-006-Epinephrine
• 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 3.6 mg, and 4mg with EpiPen 0.3mg Intramuscular Injection in Healthy Adults

Conditions

Anaphylaxis; Anaphylactic Reaction

Keywords

Anaphylaxis; Epinephrine; Nasal; spray; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Bioavailability of Epinephrine

  Plasma level of Epinephrine

  -1 to 2 hours post dose

• Blood pressure

  Pharmacodynamic response

  -1 to 4 hours post dose

• Heart rate

  Pharmacodynamic response

  -1 to 4 hours post dose

• Respiratory rate

  Pharmacodynamic response

  -1 to 4 hours post dose

Secondary Outcomes (3)

• 12-lead electrocardiogram

  -2 up to 1 hour post dose

• Adverse events

  through study completion, an average of 3 weeks

• Nasal Mucosa health status

  -1 hour until end of each dosing day, an average 3 weeks.

Study Arms (2)

6 Healthy volunteers, sequence ABC

EXPERIMENTAL

Three drug administrations to each subject, each administration on a separate day. treatment order: A B C

Drug: A: Epinephrine injection; Drug: B: FMXIN002 3.6mg; Drug: C: FMXIN002 4.0mg

6 Healthy volunteers, sequence BAC

EXPERIMENTAL

Three drug administrations to each subject, each administration on a separate day. treatment order: B A C

Drug: A: Epinephrine injection; Drug: B: FMXIN002 3.6mg; Drug: C: FMXIN002 4.0mg

Interventions

A: Epinephrine injection DRUG

Autoinjector for intramuscular, single-use, 0.3mg

Also known as: EpiPen

6 Healthy volunteers, sequence ABC; 6 Healthy volunteers, sequence BAC

B: FMXIN002 3.6mg DRUG

Nasus Pharma nasal powder spray 3.6 mg, single use in one nostril

Also known as: Epinephrine Nasal Product

6 Healthy volunteers, sequence ABC; 6 Healthy volunteers, sequence BAC

C: FMXIN002 4.0mg DRUG

Nasus Pharma nasal powder spray 4.0 mg, single use in one nostril

Also known as: Epinephrine Nasal Product

6 Healthy volunteers, sequence ABC; 6 Healthy volunteers, sequence BAC

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. 2) BMI ≥18 \< 30 kg/m2. 3) Females may be of childbearing or non-childbearing potential:
• Childbearing potential:
• o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of contraception
• Non-childbearing potential:
• Surgically sterile
• Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause).
• \) Able to tolerate venipuncture. 5) 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, ischemic heart disease or Arteriosclerosis or cardiovascular disease, autoimmune disease, or Raynaud Phenomenon and 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 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 allergy
• Known history or presence of any food allergy.
• 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 other than oral contraceptives.
• 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.
• Inability to communicate well with the Investigators and staff
• 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.

Sponsors & Collaborators

• Nasus Pharma: lead
• Hadassah Medical Organization: collaborator
• Medistat Ltd., Israel: collaborator
• Pharma Medica Research, Inc.: collaborator

Study Sites (1)

Clinical Pharmacology Unit, Hadassah Medical Center, Ein Karem

Jerusalem, 91120, Israel

Location

Related Links

• First-in-class intranasal epinephrine spray for anaphylaxis: Dose finding clinical study

MeSH Terms

Conditions

Anaphylaxis

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

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, Professor

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: To evaluate the comparative bioavailability and pharmacodynamic response between: A. Epinephrine injection, USP auto-injector 0.3 mg for intramuscular (IM) injection B. FMXIN002 epinephrine microspheres powder for nasal application, 3.6 mg and C. FMXIN002 epinephrine microspheres powder for nasal application, 4 mg and after a single-dose administration to healthy adults Secondary Objective: To evaluate the safety and tolerability of the study treatments

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 12, 2024
• Study Start: August 22, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 5, 2024
• Last Updated: June 18, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)