ISRCTN16112706进行中（未招募）1 期
A non-randomized, open-label, single-dose study to investigate the intrapulmonary penetration of RO7223280 following intravenous administration in healthy participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1. Male and female participants aged 18 to 55 years of age, inclusive, at screening
- •2. Healthy participants. Health status defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, serology, coagulation, and urinalysis
- •3. Participants must weigh at least 50 kg and must have a body mass index (BMI) within the range of 18 to 32 kg/m², inclusive
排除标准
- •1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, haematological, or allergic disease, metabolic disorder, cancer, or cirrhosis
- •2. Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
- •3. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs
- •4. History or presence of clinically significant ECG abnormalities
- •5. History of malignancy
- •6. Vaccination is prohibited within 2 months prior to Day 1
- •7. Use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within 5 times the elimination half-life, whichever is longer) prior to Day 1
- •8. Currently enrolled in, have participated in, or plan to participate in any other clinical study involving an investigational medicinal product or medical device study from within 30 days directly preceding screening or within 5 times the elimination half-life, if known (whichever is longer), until completion of the follow-up visit
- •9. Normal lung function with forced expiratory volume in the first second (FEV1) predicted =80% and FEV1/forced vital capacity (FVC) >0.7.
- •10. Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel, and urinalysis)
- •11. Evidence of human immunodeficiency virus (HIV) infection and/or positive result for human HIV antibodies
- •12. Presence of hepatitis B surface antigen or positive hepatitis C antibody test result
- •13. Participants who may not tolerate a BAL or cannot undergo a BAL because of the presence of contraindications to a BAL including suspected intolerance to medications required for bronchoscopy
- •14. History of hypersensitivity to lidocaine (and other local anaesthetics of the amino amide type) or to any of its formulation ingredients
- •15. History of hypersensitivity to any of the excipients in the formulation of RO7223280
- •16. Participants with insufficient venous access.
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