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Enrolling by invitation NCT07228325

Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis

Phase I / Phase II Interventional Anaphylaxis Allergy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FMXIN002 single dose, Epinephrine autoinjector single dose, FMXIN002 single dose + NAC, Epinephrine autoinjector double dose.
Who it may be relevant to
Registry conditions: Anaphylaxis, Allergy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Comparison of PK and PD Responses Following Single and Repeat Administration of Epinephrine Nasal FMXIN002 4.0 mg and EpiPen 0.3 mg, in Healthy Adults With Allergic Rhinitis

Overview

The study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) responses of FMXIN002, an intranasal epinephrine powder, compared with the EpiPen® intramuscular autoinjector, after single and double doses, in healthy adults with a history of allergic rhinitis.

Detailed description

Fifty participants will receive single and repeat doses of both treatments under normal and nasal congestion conditions induced by nasal allergen challenge. The study will also assess the effect of repeat nasal dosing in the same versus opposite nostrils. PK parameters and hemodynamic responses will be measured, and safety and tolerability will be evaluated.

Interventions

  • Drug FMXIN002 single dose
    Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.
  • Drug Epinephrine autoinjector single dose
    Epinephrine IM autoinjector 0.3mg
  • Drug FMXIN002 single dose + NAC
    Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)
  • Drug Epinephrine autoinjector double dose
    Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart
  • Drug FMXIN002 double dose
    Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.
  • Drug FMXIN002 double dose + NAC
    Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.

Primary outcome measures

  • Epinephrine level in plasma over time [Time frame: -60 to 240 minutes post administration]
  • Tmax [Time frame: -60 to 240 minutes post administration]
  • T100pg/ml [Time frame: -60 to 240 minutes post administration]
  • Cmax [Time frame: -60 to 240 minutes post administration]
  • AUC [Time frame: 0 to 240 minutes post administration]
  • Blood pressure [Time frame: -60 to 120 minutes post administration]
  • Heart rate [Time frame: -60 to 120 minutes post administration]
  • Respiratory rate [Time frame: -60 to 120 minutes post administration]
Secondary outcome measures (1)
  • Safety and tolerability [Time frame: Day -29 to day 50]

Eligibility criteria

Inclusion criteria

  • Non-smoking, male and female participants, from 18 to 55 years of age.
  • Documented positive skin allergy test at screening.
  • History of hay fever, seasonal allergies, or allergic rhinitis during the last year.
  • BMI ≥18 and < =30 kg/m2.
  • 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 (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 and a FSH value consistent with being postmenopausal).
  • Able to tolerate venipuncture.
  • Be informed of the nature of the study and give written consent prior to any study procedure.
  • Willing and able to remain in the clinic for the entire duration of the confinement period.
  • Have good intravenous access on both arms and hands. -

Exclusion criteria

  • History 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 participant or impact the validity of the study results.
  • Have clinically significant findings at screening.
  • Females who:
  • Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to the first drug administration;
  • Have discontinued or changed the use of oral or patch hormonal contraceptives within one (1) month prior to the first drug administration;
  • Are pregnant (serum β-hCG consistent with pregnancy); or
  • Are breast-feeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Pharma Medica Research Inc — Mississauga

Identifiers

NCT: NCT07228325 · NP-007-Epinephrine

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗