A Patient and Investigator-blinded, Randomized, Placebo Controlled Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
研究概览
简要总结
This study is designed to determine whether LLG783 displays the clinical safety and efficacy profile, after multiple i.v. doses, to support further development in patients with PAD and intermittent claudication.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •claudication, as defined by pain with exertion in either leg;
- •On stable medical therapy, including statins, aspirin, and antihypertensive medications (as medically indicated) unless individually contraindicated, for at least 4 weeks prior to the screening visit;
- •Vital signs must be within the following ranges:
- •body temperature between 35.0-37.5°C
- •systolic blood pressure, 90-159 mm Hg
- •diastolic blood pressure, 50-99 mm Hg
- •pulse rate, 50 - 90 bpm
- •Moderately impaired ambulatory function judged by the investigator to be due primarily to PAD and assessed by a maximum walk distance between 50 and 400 meters (inclusive of these values) at the screening 6-minute walk test (6MWT).
排除标准
- •Pregnant or nursing (lactating) women;
- •Patients who meet any of the following PAD related criteria:
- •Patients actively attending and participating in a supervised exercise rehabilitation program (patients who have already completed such a program and remain symptomatic may be included).
- •Patients with any condition other than PAD that limits walking ability.
- •Known inflammatory disease of the arteries (other than atherosclerosis; e.g. Thromboangiitis obliterans).
- •Clinical evidence of critical limb ischemia including new or non-healing ulcers (felt secondary to critical limb ischemia), new or recent onset of resting pain in the lower extremities particularly at night (felt secondary to critical limb ischemia) and/or gangrene of the lower extremities (Fontaine stage III-IV) .
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 150 days after stopping of investigational drug.
- •Any of the following concomitant cardiovascular or metabolic conditions or diseases:
- •Myocardial infarction within 6 months of screening.
- •Stroke within 6 months of screening.
- •History of clinically significant ventricular arrhythmias, according to the discretion of the investigator, within 6 months of screening.
- •Significant ECG abnormalities, according to the discretion of the investigator, at screening.
- •History of sustained and clinically significant supraventricular arrhythmias (e. g. associated with hemodynamic compromise) within 6 months of screening.
- •Chronic heart failure New York Heart Association Class III or IV.
- •Known presence of aortic aneurysm > 5 cm.
- •Uncontrolled diabetes as defined by a random fasting glucose level of 13 mmol/L or 240 mg/dL or a HbA1c greater than 9% as measured at screening. Diabetes should be treated as appropriate during the study.
研究组 & 干预措施
Placebo
Patients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks.
干预措施: Placebo (Drug)
LLG783
Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks.
干预措施: LLG783 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
时间窗: Up to 32 Weeks
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant.
Change From Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16
时间窗: Baseline, Week 16 (Day 113)
MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) participants. 6MWT test included measurement of total distance walked in 6 minutes.
次要结局
- Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)(1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose and 1, 2 and 4 hours postdose on Day 85)
- Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)(1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85)
- Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])(1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85)
- Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)(1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85)
- Observed Maximum Serum Concentration (Cmax) Following Drug Administration(1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85)
- Time to Reach the Maximum Concentration After Drug Administration (Tmax)(1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85)
- Change From Baseline in Pain-free Walking Distance (PFWD) as Assessed by 6-minute Walk Test at Week 16(Baseline, Week 16 (Day 113))