A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of AEs
研究概览
简要总结
Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and PK of single ascending doses of inhaled TLC19 in healthy volunteer subjects.
详细描述
A Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and PK of single ascending doses of inhaled TLC19 (Hydroxychloroquine Liposome Inhalation Suspension) in healthy volunteer subjects. Three dose levels will be assessed in sequential cohorts, with 2 mL, 4 mL, and 6 mL. Total of approximately 30 subjects will be randomized in the study in 3 cohorts. Subjects will be enrolled and randomized to receiving either TLC19 or TLC 19 Vehicle.
Drug Administration: Blinded study medication will be administered through inhalation via a portable vibration mesh nebulizer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female 18 to 65 years of age
- •Body mass index (BMI) 18.0 to 30.0 kg/m
- •Never-smoker
排除标准
- •Body weight <50 kg
- •Donation of blood (450 mL) or blood loss within 3 months prior to study
- •Contraindication, allergy, or hypersensitivity to hydroxychloroquine or chloroquine or other 4 aminoquinolines
- •Use of any prescription or OTC medications or herbal supplements within 2 weeks (or 5half-lives if longer) prior to study
- •Use of any investigational product/medical device within 30 days or 5 half-lives prior to study, or participation in ≥4 investigational drug studies within 1 year prior to study
- •History or presence of any of the following conditions:
- •Autoimmune or rheumatoid inflammatory disease
- •Cardiac disorders
- •Lung disease, prior intubation, or requiring use of an inhaler
- •Liver cirrhosis or Child-Pugh class C
- •Retinopathy or maculopathy
- •Neuromuscular diseases
- •Glucose-6 phosphate dehydrogenase deficiency
- •Hematologic malignancy
- •Chronic kidney disease or renal failure
- •Psoriasis or porphyria
- •Diabetes mellitus
- •Severe allergic or anaphylactic reactions
- •Any other significant condition that would preclude participation
- •History of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years
- •Fever or symptomatic viral or bacterial infection within 2 weeks prior to study
- •Any clinically significant laboratory abnormality
研究组 & 干预措施
TLC19 Vehicle (high dose)
TLC19 Vehicle 6ml single dose
干预措施: TLC19 Vehicle (Drug)
TLC19 (high dose)
TLC19 6ml single dose
干预措施: TLC19 (Drug)
TLC19 Vehicle (medium dose)
TLC19 Vehicle 4ml single dose
干预措施: TLC19 Vehicle (Drug)
TLC19 Vehicle (low dose)
TLC19 Vehicle 2ml single dose
干预措施: TLC19 Vehicle (Drug)
TLC19 (medium dose)
TLC19 4ml single dose
干预措施: TLC19 (Drug)
TLC19 (low dose)
TLC19 2ml single dose
干预措施: TLC19 (Drug)
结局指标
主要结局
Incidence of AEs
时间窗: 0-28 Days
To evaluate the severity, seriousness, outcome, and action taken of AE
次要结局
- Area under the blood concentration-time curve(0-168 hours)
- Maximum blood concentration(0-168 hours)
- Time to reach maximum blood concentration(0-168 hours)