EUCTR2022-003466-20-PL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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 142
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
- 性别
- All
入选标准
- •Asthma Cohorts C1 to C3: Male and nonpregnant, nonlactating volunteers aged 18 to 60 years (19 to 60 years of age, where applicable according to local regulation). Subjects must have a clinical diagnosis of asthma. Asthma severity must be mild-to-moderate, with severity measured by the type/quantity of medication required to keep the subject’s asthma under control (as detailed in the protocol). Asthma subjects must have a Screening prebronchodilator ppFEV1 =70% and blood eosinophil count =200 cells/µL. Asthma subjects must be able to produce an acceptable induced sputum sample at Screening. Asthma subjects with a recent asthma exacerbation, or ALT or AST >2×ULN, will be excluded.
- •High FeNO” Asthma Cohorts D1 and D2: Male and nonpregnant, nonlactating volunteers aged 18 to 65 years (19 to 65 years of age, where applicable according to local regulation) having a clinical diagnosis of asthma. Asthma must be treated with a stable daily maintenance controller regimen that includes inhaled corticosteroids (ICS). Asthma may not be treated with biologic therapies. Subjects must have a Screening prebronchodilator ppFEV1 =40%. In addition, subjects must have FeNO =35 ppb at all Screening visits. Asthma subjects with a recent asthma exacerbation, or ALT or AST >2×ULN, will be excluded.
- •CF Cohort E1: Male and nonpregnant, nonlactating volunteers aged 18 to 60 years (19 to 60 years of age, where applicable according to local regulation) having clinical diagnosis of CF. Subjects must be on a stable CF therapeutic regimen (including cystic fibrosis transmembrane conductance regulator [CFTR] modulator, if applicable) for 6 weeks prior to Screening. Subjects must have ppFEV1 =40% and =80% at Screening. CF subjects with a recent CF exacerbation, or ALT or AST >2.5×ULN, will be excluded.
- •Please refer to the study Protocol to see all the inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria for asthma Cohorts C1 to C3
- •1. Acute lower respiratory infection or asthma exacerbation within 30 days prior to first dose
- •2. Acute upper respiratory infection within 7 days prior to first dose
- •3. Positive COVID-19 test during Screening window. Any record of a positive test during the Screening window, whether protocol-mandated antigen test or any NAAT or antigen test obtained outside of this study, serves as a potential exclusion criterion (see below).
- •a. In the event of a positive COVID-19 test during Screening, and if the PI deems the subject clinically appropriate to proceed to study drug dosing and no other exclusion criteria are met (eg, #1 or #4), the PI may elect to proceed to randomize the subject. In such a case, the first dose may not be given until >7 days after both clinical resolution of infection and conversion of antigen test from positive to negative (if such results are available), whichever is later. If necessary, the Screening period may be extended to >28 days, but in no case will the Screening period be extended to >45 days.
- •4. Chronic or acute infection that is clinically significant or requires treatment with systemic antibiotics, antivirals, antifungals, or antiparasitics within 30 days prior to first dose.
- •a. Please note that a positive sputum bacterial culture from Study Day 1 does not meet this exclusion criterion
- •5. Use of systemic corticosteroid therapy within 90 days prior to first dose
- •6. Use of immunosuppressive medication (eg, methotrexate, cyclosporine, azathioprine, etc.) within 90 days prior to first dose. See Section 8.2.5.4 for more details.
- •7. Use of biologic therapies for asthma (ie, anti-IgE, anti-IL5/IL5R, anti-IL4R, anti-TSLP) within 16 weeks prior to first dose
- •8. Prior history of bronchial thermoplasty treatment
- •9. Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, panic attacks with hyperventilation, or other mimics of asthma
- •10. 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 ofpatient 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. Any history of organ transplant
- •12. Human immunodeficiency virus infection, as shown by presence of anti-HIV antibodies (seropositive)
- •13. Seropositive for HBV or HCV (positive result for anti-HCV antibodies must be confirmed with positive HCV RNA test for exclusion)
- •14. Uncontrolled hypertension (SBP >150 mmHg or DBP >100 mmHg) at Screening
- •15. 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. A family history of congenital long QT syndrome or unexplained sudden cardiac death
- •17. Use of medications known to prolong the QTc interval within 30 days prior to first dose (eg, azithromycin)
- •18. Use of theophylline within 30 days prior to first dose
- •19. Symptomatic heart failure (per NYHA guidelines
研究者
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