NCT00506792已完成2 期
A Two-part, Randomized, Double-blind, Placebo-controlled, Ascending Single-dose, Adaptive Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAU145 Administered Via a Nasal Spray Pump to Patients With Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Pharmacodynamic response to single intranasal doses of QAU145 in cystic fibrosis patients using nasal potential difference measurements up to 6 hours post-dose.
研究概览
简要总结
This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50.
排除标准
- •Any presence of seasonal or non-seasonal allergies affecting the nose, nasal passages, throat or sinuses within 2 weeks prior to dosing.
- •Any upper respiratory tract infection or signs or symptoms within 2 weeks prior to dosing.
- •Any presence of nasal polyps or structural abnormalities, frequent history of nose bleeding, or any recent nasal surgery (within 12 weeks prior to dosing).
研究组 & 干预措施
1
Experimental
QAU145
干预措施: QAU145 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamic response to single intranasal doses of QAU145 in cystic fibrosis patients using nasal potential difference measurements up to 6 hours post-dose.
时间窗: Part I: Baseline, 2 hr post dose, after each dose, end of Part I. Part II: Pre dose and 2 hours post each dose
次要结局
- Safety and tolerability of single ascending doses assessed by nasal examinations, adverse events, medications, and a nasal symptom questionnaire. Pharmacokinetics up to 6 hours post-dose(Part I: Throughout study (about 8 weeks) Part II: Throughout study (about 9 weeks))
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult SubjectsHealthy Adult SubjectsNCT06635226IlDong Pharmaceutical Co Ltd36
已完成
1 期
Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy ParticipantsHealthyNCT05428696Alexion Pharmaceuticals, Inc.90
终止
2 期
A Study of RO5186582 in Down Syndrome Among Children 6 to 11 Years of AgeDown SyndromeNCT02484703Hoffmann-La Roche45
已完成
1 期
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male ParticipantsHealthy VolunteersNCT01964872Janssen Cilag N.V./S.A.84
已完成
1 期
An Evaluation of VR942 in Healthy Volunteers and Patients With Mild AsthmaAsthmaNCT02473939Vectura Limited85