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

Nasus Pharma1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2025年11月3日最近更新: 2025年11月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: Enrolling By Invitation
发起方: Nasus Pharma
入组人数: 50
试验地点: 1
主要终点: Epinephrine level in plasma over time

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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/m
•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. -

排除标准

•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.

研究组 & 干预措施

FMXIN002 Repeated doses in the same nostril

Experimental

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

干预措施: FMXIN002 single dose (Drug)

FMXIN002 Repeated doses in the same nostril

Experimental

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

干预措施: Epinephrine autoinjector single dose (Drug)

FMXIN002 Repeated doses in the same nostril

Experimental

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

干预措施: FMXIN002 single dose + NAC (Drug)

FMXIN002 Repeated doses in the same nostril

Experimental

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

干预措施: Epinephrine autoinjector double dose (Drug)

FMXIN002 Repeated doses in the same nostril

Experimental

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

干预措施: FMXIN002 double dose (Drug)

FMXIN002 Repeated doses in the same nostril

Experimental

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

干预措施: FMXIN002 double dose + NAC (Drug)