A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
研究概览
简要总结
The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.
Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.
详细描述
The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011.
In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acceptable results on pulmonary function tests
- •At rest oxygen saturation ≥90% on room air
- •Adequate organ function
排除标准
- •High resolution computer tomography pattern showing emphysema that is greater than fibrosis
- •Acceptable results on whole body plethysmography
- •History of clinically significant hepatic or renal disease
- •Poorly controlled or severe diabetes mellitus
- •Use of systemic immunosuppressants within 28 days of GS-6624 infusion
研究组 & 干预措施
GS-6624 125mg
干预措施: GS-6624 (Drug)
Experimental: GS-6624 200mg
干预措施: GS-6624 (Drug)
结局指标
主要结局
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
时间窗: 113 days
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).
次要结局
- - To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ(113 Days)