AnaphylaxisPhase 1/2NCT06205134
Comparative Bioavailability of Intranasal Epinephrine
A Phase 1/2 study testing A: Epinephrine injection, B: FMXIN002 3.6mg and C: FMXIN002 4.0mg in people with Anaphylaxis and Anaphylactic Reaction, run by Nasus Pharma at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis, Anaphylactic Reaction
- What is being tested?
- A: Epinephrine injection, B: FMXIN002 3.6mg and C: FMXIN002 4.0mg
- 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
- 22 Aug 2023to 5 Feb 2024
- Phase
- Phase 1/2
- 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
- 1) 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).
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- 4) Able to tolerate venipuncture. 5) Be informed of the nature of the study and give written consent prior to any study procedure.
- 6) Willing and being able to remain in the clinic for the entire duration of the confinement period.
- 7) Have good intravenous access on both arms and hands.
Who cannot join
- 1) 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).
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- 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.
- 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 (Urine 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 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 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
Clinical Pharmacology Unit, Hadassah Medical Center, Ein Karem
Jerusalem, 91120
About this study
Official title: A Study to Compare the Bioavailability of Epinephrine Following a Single Nasal Dose of FMXIN002 Microspheres Powder 3.6mg, and 4mg With EpiPen 0.3mg Intramuscular Injection in Healthy Adults
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
Read the detailed description
An open-label trial in 12 healthy adults. FMXIN002 (3.6 mg and 4.0 mg) will be administered intranasally to healthy adults and compared to IM (0.3mg, EpiPen) by Epinephrine pharmacokinetics, pharmacodynamic response and clinical safety.
(https://my.health.gov.il/CliniTrials/Pages/MOH_2023-07-01_012776.aspx.)
- Conditions
- Anaphylaxis, Anaphylactic Reaction
- Being tested
- A: Epinephrine injection, B: FMXIN002 3.6mg, C: FMXIN002 4.0mg
- Keywords
- Anaphylaxis, Epinephrine, Nasal, spray, Pharmacokinetics
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: Epinephrine injectionDrug
Also called EpiPen
Autoinjector for intramuscular, single-use, 0.3mg
B: FMXIN002 3.6mgDrug
Also called Epinephrine Nasal Product
Nasus Pharma nasal powder spray 3.6 mg, single use in one nostril
C: FMXIN002 4.0mgDrug
Also called Epinephrine Nasal Product
Nasus Pharma nasal powder spray 4.0 mg, single use in one nostril
| Study group | Role | What they receive |
|---|---|---|
| 6 Healthy volunteers, sequence ABC | Experimental | Three drug administrations to each subject, each administration on a separate day.
treatment order: A B C Receives: 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 Receives: Drug: A: Epinephrine injection; Drug: B: FMXIN002 3.6mg; Drug: C: FMXIN002 4.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of Epinephrine
Plasma level of Epinephrine
Measured: -1 to 2 hours post dose
Blood pressure
Pharmacodynamic response
Measured: -1 to 4 hours post dose
Heart rate
Pharmacodynamic response
Measured: -1 to 4 hours post dose
Respiratory rate
Pharmacodynamic response
Measured: -1 to 4 hours post dose
Secondary outcomes (3)
12-lead electrocardiogram
Safety
Measured: -2 up to 1 hour post dose
Adverse events
Safety
Measured: through study completion, an average of 3 weeks
Nasal Mucosa health status
- Nasal cavity examination by physician, recorded on a severity scale
- Nasal and Non-Nasal Questionnaire of symptomes, completed by the subjects, using a severity scale.
Measured: -1 hour until end of each dosing day, an average 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start22 Aug 2023
- Primary completion2 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization, Medistat Ltd., Israel, Pharma Medica Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Yoseph Caraco, Professor, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205134
- Sponsor's protocol ID
- NP-006-Epinephrine
- Status last verified
- Mar 2024
- First submitted
- 18 Dec 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Bioavailability of Epinephrine Following a Single Nasal Dose of FMXIN002 Microspheres Powder 3.6mg, and 4mg With EpiPen 0.3mg Intramuscular Injection in Healthy Adults
- ClinicalTrials.gov ID
- NCT06205134
- Acronym / sponsor ID
- NP-006-Epinephrine
- Conditions
- Anaphylaxis, Anaphylactic Reaction
- Keywords
- Anaphylaxis, Epinephrine, Nasal, spray, Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nasus PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization, Medistat Ltd., Israel, Pharma Medica Research, Inc.
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
An open-label trial in 12 healthy adults. FMXIN002 (3.6 mg and 4.0 mg) will be administered intranasally to healthy adults and compared to IM (0.3mg, EpiPen) by Epinephrine pharmacokinetics, pharmacodynamic response and clinical safety.
(https://my.health.gov.il/CliniTrials/Pages/MOH_2023-07-01_012776.aspx.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 6 Healthy volunteers, sequence ABC | Experimental | Drug: A: Epinephrine injection, Drug: B: FMXIN002 3.6mg, Drug: C: FMXIN002 4.0mgThree drug administrations to each subject, each administration on a separate day. treatment order: A B C |
| 6 Healthy volunteers, sequence BAC | Experimental | Drug: A: Epinephrine injection, Drug: B: FMXIN002 3.6mg, Drug: C: FMXIN002 4.0mgThree drug administrations to each subject, each administration on a separate day. treatment order: B A C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 1) 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:
- o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of contraception
- 4) Able to tolerate venipuncture. 5) Be informed of the nature of the study and give written consent prior to any study procedure.
- 6) Willing and being able to remain in the clinic for the entire duration of the confinement period.
- 7) Have good intravenous access on both arms and hands.
Key exclusion criteria (53 listed)
- 1) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A: Epinephrine injectionAlso: EpiPenAutoinjector for intramuscular, single-use, 0.3mg | Drug | 6 Healthy volunteers, sequence ABC, 6 Healthy volunteers, sequence BAC |
| B: FMXIN002 3.6mgAlso: Epinephrine Nasal ProductNasus Pharma nasal powder spray 3.6 mg, single use in one nostril | Drug | 6 Healthy volunteers, sequence ABC, 6 Healthy volunteers, sequence BAC |
| C: FMXIN002 4.0mgAlso: Epinephrine Nasal ProductNasus Pharma nasal powder spray 4.0 mg, single use in one nostril | Drug | 6 Healthy volunteers, sequence ABC, 6 Healthy volunteers, sequence BAC |
Primary outcome
Bioavailability of Epinephrine
Time frame: -1 to 2 hours post dose
Plasma level of Epinephrine
Blood pressure
Time frame: -1 to 4 hours post dose
Pharmacodynamic response
Heart rate
Time frame: -1 to 4 hours post dose
Pharmacodynamic response
Respiratory rate
Time frame: -1 to 4 hours post dose
Pharmacodynamic response
3 secondary outcomes
12-lead electrocardiogram
Time frame: -2 up to 1 hour post dose
Adverse events
Time frame: through study completion, an average of 3 weeks
Nasal Mucosa health status
Time frame: -1 hour until end of each dosing day, an average 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- First-in-class intranasal epinephrine spray for anaphylaxis: Dose finding clinical studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoseph Caraco, Professor principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A: Epinephrine injection, B: FMXIN002 3.6mg and C: FMXIN002 4.0mg in people with Anaphylaxis and Anaphylactic Reaction, 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 9 inclusion and 53 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 18 Jun 2025. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Bioavailability of Epinephrine (time frame: -1 to 2 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?
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 18 Jun 2025.