NCT00034515已完成1 期
Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- assess safety and tolerability
研究概览
简要总结
The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 40-70% (adults)
- •FEV1 >/=50% (pediatrics)
- •oxygen saturation >90%
- •clinically stable
- •willing to stay overnight
排除标准
- •abnormal renal or liver function
- •receiving corticosteroids exceeding 10mg/day or 20 mg every other day
- •received intravenous or aerosolized antibiotics 1 week prior to dosing
结局指标
主要结局
assess safety and tolerability
次要结局
- assess effects of INS37217 on sputum weight and symptoms
研究者
相似试验
已完成
1 期
A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular CarcinomaSolid TumorNon-Small Cell Lung Cancer RecurrentHepatocellular Carcinoma RecurrentNCT02423343Eli Lilly and Company41
已完成
1 期
A Phase 1b Study to Assess the Safety, Tolerability, PK and PD of MG1113 in Hemophilia PatientHemophiliaNCT05493631GC Biopharma Corp15
终止
1 期
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)Fungal InfectionsNCT01716234Merck Sharp & Dohme LLC142
招募中
1 期
Study of SRP-1001 in Adult and Adolescent Participants With Facioscapulohumeral Muscular Dystrophy Type 1Muscular Dystrophy, FacioscapulohumeralNCT06131983Sarepta Therapeutics, Inc.60
已完成
1 期
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis CChronic Hepatitis C InfectionGenotype 1NCT01194037HanAll BioPharma Co., Ltd.30