A Phase 1, Randomized, Placebo-Controlled, Double Blind Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of SPL84
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results
研究概览
简要总结
This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male adults 18 to 50 years old
- •Considered healthy based on medical history, physical examination, 12-lead ECG and clinical laboratory results
- •Body Mass Index (BMI) 19.0-30.0 kg/m2
- •Subjects who have no difficulties in receiving drugs by inhalation
排除标准
- •A major surgical procedure or significant traumatic injury within 28 days prior to study intervention administration
- •Recent diagnosis of lung disease (< 12 weeks from planned enrollment)
- •Any acute illness (e.g. acute infection) within 48 hours prior to the study intervention administration, which is considered of clinical significance by the Investigator.
- •Chronic respiratory disease including but not limited to obstructive airway disease such as asthma or chronic obstructive pulmonary disease (COPD); restrictive disease such as idiopathic pulmonary fibrosis (IPF); or pulmonary vascular disease such as pulmonary arterial hypertension (PAH).
- •History of adverse reactions during aerosol delivery of any medicinal product.
- •Total body weight ≤50 kg at screening.
- •Abnormal forced expiratory volume at one second (FEV1) at screening.
- •Oxygen saturation ≤95% at screening.
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP) and bilirubin (total and direct) above upper limit of normal (ULN) at screening and clinically significant
- •Supine systolic blood pressure <90 or >140 mmHg, supine diastolic blood pressure <50 or >90 mmHg, heart rate <45 or >100 beats per minute (bpm), or elevated body temperature (>38ºC) at screening
- •Clinically significant ECG abnormalities at screening
- •Positive for SARS-CoV-19 at screening or Day -1 (baseline).
- •Positive serology tests for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening.
- •Positive urine drug, tobacco, and breath alcohol test result at screening or Day -1 (baseline).
- •Use of any prescription or over-the-counter (OTC) medications, including vitamins and herbal or dietary supplements within 14 days prior to dosing.
- •Subjects who have received any vaccines within 4 weeks prior to study intervention administration.
- •History or current drug/alcohol abuse (excluding use of medicinal cannabis for pain management).
- •History of smoking or vaping within 180 days (6 months) of screening
研究组 & 干预措施
SPL84
干预措施: SPL84 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs)
时间窗: Day 1 through Day 31
Incidence, nature, and severity of AEs and SAEs
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters
时间窗: Day 1 through Day 31
using an ECG machine that automatically calculates heart rate and measure PR, QRS, QT, and QTc intervals
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal respiratory rate
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal systolic and diastolic blood pressure
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal temperature
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results
时间窗: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings
时间窗: Day 1 through Day 31
Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal Pulmonary function tests results
时间窗: Day 1 through Day 31
Pulmonary function tests will be performed according to the ATS/ERS and FEV1, FVC, and FEF25-75 will be measured
次要结局
- Characterization of PK of SPL84: maximum serum concentration (Cmax)(Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.)
- Characterization of PK of SPL84: Time to Cmax (Tmax)(Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.)
- Characterization of PK of SPL84: terminal elimination half-life (t1/2)(Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.)
- Characterization of PK of SPL84: Area under the curve to the final sample (AUC0-t)(Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.)
- Characterization of PK of SPL84: Area under the curve to infinity (AUC0-∞)(Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.)
- Characterization of PK of SPL84: Apparent clearance (CL/F)(Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.)