NCT00125385已完成1 期
Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis
Genzyme, a Sanofi Company8 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF
研究概览
简要总结
This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent prior to any study-related procedures.
- •Patients should have an established diagnosis of IPF.
- •Pulmonary Function Tests (PFTs): FVC ≥ 50% and DLCO ≥ 25% of normal predicted values.
- •Able to walk at least 500 feet (150 meters) during the 6-minute Walk Test (6MWT). During the 6MWT the patient must not require greater than 51/min supplemental oxygen to maintain oxygen saturation > 80%
排除标准
- •Women who are pregnant or lactating; or who plan to become pregnant within 9 months after the infusion.
- •Women of childbearing potential or men who are considering fathering a child unless taking medically acceptable contraceptive precautions;
- •History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin.
- •History of clinically significant respiratory diseases other than IPF.
- •History of clinically significant cardiac, hepatic, or renal disease.
- •History of cancer, precancerous state (e.g. familial polyposis, BRCA1, BRCA2), other than non-melanomatous skin cancer, within 5 years prior to Screening.
- •Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening.
- •Other pathology that might interfere with the assessment of the safety or efficacy of the test article.
- •Other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.
结局指标
主要结局
To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF
时间窗: up to 3 years
次要结局
- To evaluate potential clinical outcomes and bioactivity of GC1008(up to 3 years)
研究者
研究点 (8)
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