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AnaphylaxisPhase 1NCT04696822

Bioavailability of Nasal Epinephrine

A Phase 1 study testing Epinephrine Nasal Product, 1.6 mg, Epinephrine nasal product, 1.6 mg + allergen and Epinephrine Injection 0.3 mg in people with Anaphylaxis, run by Nasus Pharma at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Anaphylaxis
What is being tested?
Epinephrine Nasal Product, 1.6 mg, Epinephrine nasal product, 1.6 mg + allergen and Epinephrine Injection 0.3 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteIsrael
Study dates
1 Nov 2020to 28 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The following inclusion criteria will be assessed at screening (within 28 days prior to the first drug administration):
  • 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:
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  • 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.
  • -

Who cannot join

  • 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.
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  • 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;
  • Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration;
  • Are pregnant (serum hCG consistent with pregnancy); or
  • Are lactating.
  • Donation or loss of whole blood (including clinical trials):
  • ≥50 mL and <500 mL within 30 days prior to drug administration;
  • ≥500 mL within 56 days prior to drug administration. Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
  • On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
  • Have had a tattoo or body piercing within 30 days prior to drug administration. Have clinically significant findings in vital signs measurements at screening. Systolic blood pressure increase or decrease in value by more than 20 mmHg and/or diastolic blood pressure decrease in value by more than 10 mmHg, from supine or sitting to standing position during orthostatic blood pressure measurement taken at screening.
  • Have clinically significant findings in a 12-lead ECG. Have clinically significant abnormal laboratory values and hemoglobin <135 g/L for males or <120 g/L for females at screening.
  • Have significant diseases at the screening. Have clinically significant findings from a physical examination.
  • Use of the following drugs within 14 days prior to drug administration:
  • Alpha-adrenergic blocking drugs (e.g., phentolamine);
  • Anti-arrhythmics;
  • Beta-adrenergic blocking drugs (e.g., propranolol);
  • Cardiac glycosides;
  • Diuretics;
  • Drugs having an effect on cytochrome P450 (CYP450);
  • Enzyme-altering drugs (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine, etc.);
  • Enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism;
  • Ergot alkaloids;
  • Levothyroxine sodium;
  • Monoamine oxidase inhibitors;
  • Oral or topical corticosteroids;
  • Phenylephrine;
  • Reserpine-type or clonidine-type antihypertensives;
  • Sodium cromoglycate; or
  • Tricyclic antidepressants.
  • Use of the following drugs within 7 days prior to drug administration:
  • Nasal decongestants;
  • Nonsteroidal anti-inflammatory drugs (NSAIDs); or
  • Oral or topical antihistamines.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah Medical Center, Ein Kerem

    Jerusalem

Other trials in Israel

About this study

Official title: Bioavailability Comparison of Epinephrine Following a Single Nasal Dose of Microspheres Powder With Epinephrine Intramuscular Injection in Adults With Seasonal Allergic Rhinitis With and Without Nasal Allergen Challenge

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

Read the detailed description

Study Design: Open-label, single-dose, two-period, three-treatment, fixed-sequence, comparative bioavailability study Study Population: Non-smoking, male and female subjects, from 18 to 55 years of age with known history of hay fever, seasonal allergies, or rhinitis during the last year.

Conditions
Anaphylaxis
Being tested
Epinephrine Nasal Product, 1.6 mg, Epinephrine nasal product, 1.6 mg + allergen, Epinephrine Injection 0.3 mg, Epinephrine Nasal Product, 3.2 mg, Epinephrine Nasal Product, 3.2 mg + allergen
Medical subject headings
Anaphylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epinephrine Nasal Product, 1.6 mgDrug

    Also called FMXIN002 Microspheres Powder

    Single dose Nasal powder spray without allergen challenge

  • Epinephrine nasal product, 1.6 mg + allergenDrug

    Also called FMXIN002 Microspheres Powder

    Single dose Nasal powder spray with allergen challenge

  • Epinephrine Injection 0.3 mgDrug

    Also called EpiPen

    Intramuscular injection

  • Epinephrine Nasal Product, 3.2 mgDrug

    Also called FMXIN002 Microspheres Powder, double dose

    Twice dose Nasal powder spray without allergen challenge

  • Epinephrine Nasal Product, 3.2 mg + allergenDrug

    Also called FMXIN002 Microspheres Powder, double dose

    Twice dose Nasal powder spray with allergen challenge

Study groups in NCT04696822
Study groupRoleWhat they receive
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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epinephrine in blood - Cmax

    pharmacokinetic analysis

    Measured: -1 hour to 8 hours post-dose

  2. Epinephrine in blood- Tmax

    pharmacokinetic analysis

    Measured: -1 hour to 8 hours post-dose

  3. Epinephrine in blood- AUC

    pharmacokinetic analysis

    Measured: -1 hour to 8 hours post-dose

  4. Epinephrine in blood- T half

    pharmacokinetic analysis

    Measured: -1 hour to 8 hours post-dose

Secondary outcomes (19)

  1. body temperature

    Safety Monitoring

    Measured: morning

  2. Hemoglobin level in blood

    Safety Monitoring, blood test

    Measured: at check-in morning

  3. blood hematocrit

    Safety Monitoring: the ratio of the volume of red blood cells to the total volume of blood

    Measured: check-in morning

  4. Blood pressure

    Vital signs

    Measured: Prior to drug administration

  5. Pulse

    Vital signs

    Measured: Prior to drug administration

  6. Blood pressure

    Vital signs

    Measured: 15 minutes

  7. Pulse

    Vital signs

    Measured: 15 minutes

  8. Blood pressure

    Vital signs

    Measured: 30 minutes

  9. Pulse

    Vital signs

    Measured: 30 minutes

  10. Blood pressure

    Vital signs

    Measured: 45 minutes

  11. Pulse

    Vital signs

    Measured: 45 minutes

  12. Blood pressure

    Vital signs

    Measured: 1 hour

  13. Pulse

    Vital signs

    Measured: 1 hour

  14. Blood pressure

    Vital signs

    Measured: 2 hours

  15. Pulse

    Vital signs

    Measured: 2 hours

  16. Blood pressure

    Vital signs

    Measured: 4 hours post-dose

  17. Pulse

    Vital signs

    Measured: 4 hours post-dose

  18. electrocardiogram

    Safety Monitoring

    Measured: 3 hours prior to drug administration

  19. electrocardiogram

    Safety Monitoring

    Measured: 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start1 Nov 2020
  3. Primary completion28 Sep 2021
  4. Study completion28 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Open-label, single-dose, two-period, three-treatment, fixed-sequence, comparative bioavailability study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696822
Sponsor's protocol ID
NP-002
Status last verified
Oct 2021
First submitted
1 Dec 2020
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37394178

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epinephrine Nasal Product, 1.6 mg, Epinephrine nasal product, 1.6 mg + allergen and Epinephrine Injection 0.3 mg in people with Anaphylaxis, run by Nasus Pharma at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epinephrine in blood - Cmax (time frame: -1 hour to 8 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04696822, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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