Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of Inhaled Nezulcitinib (TD-0903) Administered in the Setting of Supplemental Oxygenation Scenarios in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- AUC0-inf
研究概览
简要总结
This is a Phase 1 pharmacokinetic (PK) study in healthy participants to assess the plasma pharmacokinetics, safety, and tolerability of a single inhaled dose of nezulcitinib (TD-0903) with supplemental oxygenation.
详细描述
A Phase 1, open-label, fixed-sequence, 4-period study to evaluate the plasma PK, safety and tolerability of single inhaled doses of nezulcitinib (TD-0903) administered under different supplemental oxygenation scenarios in healthy participants.
Approximately 14 healthy adult male and female participants will receive a single inhaled dose of nezulcitinib using a nebulizer device on Day 1 of each administration period, under different supplementary oxygenations conditions.
Administration A: Dose A nezulcitinib delivered by nasal inhalation via the Aerogen Solo with a high-flow nasal cannula circuit delivering supplemental oxygen, Administration B: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a low-flow nasal cannula delivering supplemental oxygen, Administration C: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a high-flow nasal cannula delivering supplemental oxygen, Administration D: Nezulcitinib delivered by inhalation. Route to be determined based on data from administration A-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 and weighs at least 50 kg at screening
- •Medically healthy with no clinically significant medical history, physical examination, spirometry, laboratory profiles, vital signs or ECGs
- •Forced expiratory volume of 1 second (FEV1) ≥80% predicted at screening and prior to dosing
- •No clinically significant abnormalities in the results of laboratory
- •Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method
- •Male subjects must agree to use condoms to prevent potential fetal or partner exposure through seminal fluid, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential
- •Able to understand the correct technique for the use of the nebulizer device
- •Other inclusion criteria apply
排除标准
- •History or presence of clinically significant medical or psychiatric condition
- •Abnormal ECG measurements at screening
- •Any signs of respiratory tract infection within 6 weeks of screening
- •Has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to screening
- •Has any condition of the oro-laryngeal or respiratory tract
- •History or presence of alcoholism or drug abuse
- •Positive urine drugs of abuse test
- •Positive urine or breath alcohol results
- •Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
- •Tests positive for active COVID-19
- •Additional exclusion criteria apply
研究组 & 干预措施
Administration Scenario A
Single dose of TD-0903 at Dose A on Day 1, Period 1 delivered by nasal inhalation via nebulizer device with a high-flow nasal cannula delivering supplemental oxygen
干预措施: Nezulcitinib (TD-0903) Dose A (Drug)
Administration Scenario B
Single dose of TD-0903 at Dose A on Day 1, Period 2 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via low-flow nasal cannula
干预措施: Nezulcitinib (TD-0903) Dose A (Drug)
Administration Scenario C
Single dose of TD-0903 at Dose A on Day 1, Period 3 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via high-flow nasal cannula
干预措施: Nezulcitinib (TD-0903) Dose A (Drug)
Administration Scenario D
Single dose of TD-0903 at Dose B on Day 1, Period 4 delivered by a route to-be-determined based on data from Scenarios A, B and C.
干预措施: Nezulcitinib (TD-0903) Dose B (Drug)
结局指标
主要结局
AUC0-inf
时间窗: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
The area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) of TD-0903
AUC0-t
时间窗: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
The area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-0903
Cmax
时间窗: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Maximum observed concentration (Cmax) of TD-0903 in plasma
次要结局
- Adverse Events(Day 1 through 7 following dosing on Day 1 in each of 4 Periods)