A Randomized, Open-label, Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects and the Effect of Pretreatment With Cromolyn Sodium or Albuterol Sulfate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of participants with treatment emergent, treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
研究概览
简要总结
This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.
详细描述
Healthy subjects (8 per cohort) will be randomized to either pre-treatment or no pre-treatment (4 per group). The initial cohort will receive pre-treatment with cromolyn sodium. Subjects will be followed for 2 weeks for safety and tolerability, undergo a 2 week washout period and then be assigned to the alternative treatment (i.e., subjects who received cromolyn sodium prior to PUL-042 inhalation solution will not receive pretreatment) and then followed for an additional 2 weeks.
Subsequent cohort will receive pre-treatment with albuterol sulfate in a like manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo oophorectomy or post- menopausal for > 2 years) with a negative urine human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit
- •Body Mass Index (BMI) between 18 and 30 kg/m2
- •Ability to perform spirometry according to American Thoracic Society standards
- •Normal spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC] ≥ 80% and ≤ 120% based on predicted values) at the Screening Visit and at Visit
- •Pulse oximetry ≥95% on room air
- •Ability to understand and give informed consent
- •Males willing to practice contraception (condom + spermicide) during the study and for 30 days after completion of the
排除标准
- •Febrile (temperature ≥ 99.5°Fahrenheit)
- •A history of use of any tobacco products during the year prior to the Screening Visit and a total exposure of > 5 pack years or a positive urine cotinine level at the Screening Visit
- •Clinically significant laboratory finding as determined by the Principal Investigator or designee at the Screening Visit or at Visit 2
- •Positive test for drugs of abuse (alcohol, cannabinoids, opiates, cocaine, amphetamine, barbiturates, benzodiazepine, phencyclidine)
- •Any active medical problems requiring treatment
- •Subjects who exhibit symptoms of respiratory infection or have experienced respiratory symptoms of an upper respiratory infection within 30 days prior to the Screening Visit.
- •History of chronic pulmonary disease (eg, asthma [including atopic asthma, exercise induced asthma, or asthma triggered by respiratory infection], pulmonary fibrosis), pulmonary hypertension, or heart failure
- •Any out of range QTc Fridericia (QTcF) or other clinically significant ECG findings as determined by the Principal Investigator or designee at Visit 2 or Visit
- •History of atopic reactions
- •Administration of any anti-inflammatory therapy (eg, no steroidal anti-inflammatory drugs or corticosteroids) within 4 weeks prior to randomization or expected to be ongoing during the study
- •An anticipated need for use of any inhaled medication during the study
- •Intake of coffee, tea, cola drinks, chocolate on days of Study Visits 1-21
- •Intake of alcohol, caffeine or strenuous exercise within 72 hours prior to study drug administration or intake of grapefruit within 7 days prior to the administration of study drug
- •Intake of alcohol within 4 hours of spirometry; smoking within 1 hour of spirometry; performing vigorous exercise within 30 minutes of spirometry; wearing clothing that substantially restricts full chest and abdominal expansion; or eating a large meal within 2 hours of spirometry
- •Administration of any over the counter (OTC)/prescription medication, supplements, herbals or vitamins within 14 days prior to study drug administration. Administration of Tylenol within 72 hours of study drug administration (doses up to 2g/day will be allowed prior to 72 hours before study drug administration)
- •Exposure to any investigational agent within 30 days prior to the Screening Visit
- •Receipt of a flu vaccine in the last 3 months
- •Prior exposure to PUL-042
- •Known positive for human immunodeficiency virus, or on active anti-retroviral therapy and known hepatitis B surface antigen positive or hepatitis C positive
研究组 & 干预措施
PUL-042
PUL-042 Inhalation Solution
干预措施: PUL-042 Inhalation Solution (Drug)
Cromolyn sodium
Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration
干预措施: PUL-042 Inhalation Solution (Drug)
Cromolyn sodium
Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration
干预措施: Cromolyn Sodium (Drug)
Albuterol sulfate
Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration
干预措施: PUL-042 Inhalation Solution (Drug)
Albuterol sulfate
Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration
干预措施: Albuterol sulfate (Drug)
结局指标
主要结局
Number of participants with treatment emergent, treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
时间窗: 6 weeks
次要结局
未报告次要终点