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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Epinephrine level in plasma over time [Срок оценки: -60 to 240 minutes post administration]
• Tmax [Срок оценки: -60 to 240 minutes post administration]
• T100pg/ml [Срок оценки: -60 to 240 minutes post administration]
• Cmax [Срок оценки: -60 to 240 minutes post administration]
• AUC [Срок оценки: 0 to 240 minutes post administration]
• Blood pressure [Срок оценки: -60 to 120 minutes post administration]
• Heart rate [Срок оценки: -60 to 120 minutes post administration]
• Respiratory rate [Срок оценки: -60 to 120 minutes post administration]

Вторичные конечные точки (1)

• Safety and tolerability [Срок оценки: Day -29 to day 50]

Критерии участия

Критерии включения

• 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. -

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Pharma Medica Research Inc — Mississauga

Идентификаторы

NCT: NCT07228325 · NP-007-Epinephrine

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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