A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 81
- 试验地点
- 47
- 主要终点
- Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)
研究概览
简要总结
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 40 years of age
- •Documented diagnosis of IPF
排除标准
- •History of clinically significant cardiovascular disease, including myocardial infarction, unstable ischemic heart disease, congestive heart failure, or angina during the 6 months before screening
- •Sinoatrial or atrioventricular block, uncontrolled hypertension
- •Active bleeding or current clinically significant coagulopathy
研究组 & 干预措施
Placebo
Administered IV and SC
干预措施: Placebo (Drug)
Garadacimab
Administered IV and SC
干预措施: Garadacimab (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)
时间窗: Up to 22 weeks
A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event.
Percentage of Participants With TE SAEs
时间窗: Up to 22 weeks
A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event
Number of Participants With TE Adverse Events of Special Interests (AESIs)
时间窗: Up to 22 weeks
The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis \[e.g., localized thrombosis associated with vascular access\] was not considered an AESI), and Severe hypersensitivity including anaphylaxis.
Percentage of Participants With TE-AESIs
时间窗: Up to 22 weeks
The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis \[e.g., localized thrombosis associated with vascular access\] was not considered an AESI), and Severe hypersensitivity including anaphylaxis.
Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma
时间窗: At Day 36 and Day 92 after the first treatment
Percentage of Participants With Garadacimab Induced ADAs in Plasma
时间窗: At Day 36 and Day 92 after the first treatment
Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)
时间窗: Up to 14 weeks after treatment
Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs
时间窗: Up to 14 weeks after treatment
次要结局
- Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab(At Day 36 and Day 64)
- Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab(After dosing on Day 64)
- Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab(After dosing on Day 64)
- Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab(After dosing on Day 64)
- Ctrough After IV Administration of Garadacimab(At Day 8)
- Cmax After IV Administration of Garadacimab(After dosing on Day 1)
- Tmax After IV Administration of Garadacimab(After dosing on Day 1)
- Mean Change From Baseline in FXIIa-mediated Kallikrein Activity(Baseline and at Day 92)
- Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity(Baseline and at Day 92)