CTIS2023-509654-60-00招募中1 期
A Phase 1/2a Study Evaluating the Effects of ARO-RAGE Inhalation Solution in Healthy Subjects and Patients with Inflammatory Lung Disease - ARORAGE-1001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Asthma Cohorts C1-C3: Male or nonpregnant, nonlactating female volunteers., 10. Asthma Cohorts C1-C3: Able and willing to provide written informed consent prior to the performance of any study-specific procedures., 11. Asthma Cohorts C1-C3: BMI between 18.0 and 35.0 kg/m2 at Screening., 12. Asthma Cohorts C1-C3: A 12-lead ECG at Screening with no abnormalities that may compromise the participant’s safety in this study., 13. Asthma Cohorts C1-C3: Nonsmoker (defined as someone who has not smoked a cigarette for at least 6 months) with current nonsmoking status confirmed by urine cotinine at Screening AND previous smoking history prior to 6 months must be <10 pack-years. Subjects may be on nicotine replacement (patch or gum). Nicotine e-cigarettes (vapor) are not permitted. A positive urine cotinine result due to nicotine replacement is acceptable for enrollment at the discretion of the PI., 14. Asthma Cohorts C1-C3: Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later., 15. Asthma Cohorts C1-C3: Able and willing to comply with all study assessments and adhere to the protocol schedule., 16. Asthma Cohorts C1-C3: Able to produce an induced sputum sample at Screening that meets the criteria of acceptable quality., 17. Asthma Cohorts D1 and D3: Male or nonpregnant, nonlactating female volunteers, 18. Asthma Cohorts D1 and D3: Age 18 to 65 years at Screening. Age 19 to 65 years at Screening, where applicable according to local regulation., 19. Asthma Cohorts D1 and D3: Physician-diagnosed asthma, which must have been confirmed and documented (based on source verifiable medical record) for at least 12 months prior to Screening., 2. Asthma Cohorts C1-C3: Age 18 to 60 years at Screening. Age 19 to 60 years at Screening, where applicable according to local regulation., 20. Asthma Cohorts D1 and D3: Documented treatment with a daily maintenance asthma controller regimen that includes inhaled corticosteroid (ICS) for at least 3 months prior to Screening. ICS controller regimen may be either low, medium, or high dose ICS. Subjects who use ICS only on an as-needed basis do not qualify., 21. Asthma Cohorts D1 and D3: Prebronchodilator ppFEV1 =40% at Screening., 22. Asthma Cohorts D1 and D3: Stable dose of asthma controller medications for at least 28 days prior to Screening., 23. Asthma Cohorts D1 and D3: FeNO =35 ppb at each visit during Screening., 24. Asthma Cohorts D1 and D3: If on allergen-specific immunotherapy, patients must be on a stable maintenance dose for at least 3 months prior to first dose., 25. Asthma Cohorts D1 and D3: Chest x-ray taken at Screening that, according to the Investigator, excludes significant alternative respiratory disease., 26. Asthma Cohorts D1 and D3: Able and willing to provide written informed consent prior to the performance of any study-specific procedures., 27. Asthma Cohorts D1 and D3: BMI between 18.0 and 35.0 kg/m2 at Screening., 28. Asthma Cohorts D1 and D3: A 12-lead ECG at Screening with no abnormalities that may compromise the participant’s safety in this study., 29. Asthma Cohorts D1 and D3: Nonsmoker (defined as someone who has not smoked a cigarette for at least 6 mon
排除标准
- •1. Asthma Cohorts C1 to C3: Acute lower respiratory infection or asthma exacerbation within 30 days prior to first dose: Please note that a positive sputum bacterial culture from Study Day 1 does not meet this exclusion criterion., 10. Asthma Cohorts C1 to C3: Any concomitant pulmonary disease that, in the opinion of the Investigator and/or Medical Monitor, will interfere with the evaluation of the study drug or interpretation of patient safety or study results (including, but not limited to: COPD, interstitial lung disease, cystic fibrosis, allergic bronchopulmonary aspergillosis, bronchiectasis, tuberculosis, etc). Any concomitant pulmonary disease must be discussed with the Medical Monitor during Screening., 11. Asthma Cohorts C1 to C3: Any history of organ transplant., 12. Asthma Cohorts C1 to C3: Human immunodeficiency virus infection, as shown by presence of anti-HIV antibodies (seropositive)., 13. Asthma Cohorts C1 to C3: Seropositive for HBV or HCV (positive result for anti-HCV antibodies must be confirmed with positive HCV RNA test for exclusion)., 14. Asthma Cohorts C1 to C3: Uncontrolled hypertension (SBP >150 mmHg or DBP >100 mmHg) at Screening., 15. Asthma Cohorts C1 to C3: A history of Torsades de Pointes, ventricular rhythm disturbances (eg, ventricular tachycardia or fibrillation), pathologic sinus bradycardia (<50 bpm with symptoms), heart block (excluding first-degree block, being PR prolongation only), congenital long QT syndrome, new ST segment elevation or depression, or new Q wave on ECG. Participants with a history of atrial arrhythmias should be discussed with the Medical Monitor., 16. Asthma Cohorts C1 to C3: A family history of congenital long QT syndrome or unexplained sudden cardiac death., 17. Asthma Cohorts C1 to C3: Use of medications known to prolong the QTc interval within 30 days prior to first dose., 18. Asthma Cohorts C1 to C3: Use of theophylline within 30 days prior to first dose., 19. Asthma Cohorts C1 to C3: Symptomatic heart failure (per NYHA guidelines), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction <20%), TIA, or CVA within 24 weeks prior to first dose., 2. Asthma Cohorts C1 to C3: Acute upper respiratory infection within 7 days prior to first dose: In the case of an upper respiratory infection within 7 days of the first dose, the PI may elect to extend the Screening period to >28 days such that the first dose is given >7 days following clinical resolution of the infection. In no case will the Screening period be extended to >45 days., 20. Asthma Cohorts C1 to C3: History of malignancy within the past 2 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer. Participants with other curatively-treated malignancies who have no evidence of metastatic disease and >2-year disease-free interval may be entered following approval by the Medical Monitor., 21. Asthma Cohorts C1 to C3: History of major surgery within 12 weeks prior to first dose., 22. Asthma Cohorts C1 to C3: Unwilling to limit alcohol consumption to within moderate limits for the duration of the study, as follows: not more than 14 units per week for women and 21 units per week for men (1 unit=150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol)., 23. Asthma Cohorts C1 to C3: Use of illicit drugs (such as cocaine or PCP) within 1 year prior to Screening or positive urine drug screen at Screening (a urine drug
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