Inflammation and abnormal amount of lipids in the blood are key factors for the development and progression of atherosclerosis (thickening of the artery wall) and cardiovascular disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects, including endothelial dysfunction and migration of white blood cells into the vessel wall, which results in increased risk of cardiovascular events. This study is designed to assess the effects of multiple monthly intravenous infusions with the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
Monthly treatment for 3 months (4 administrations)
Monthly treatment for 3 months (4 administrations)
Department of Vascular Medicine, Academic Medical Center
Amsterdam, Netherlands
CTC Clinical Trial Consultants AB
Uppsala, Sweden
Monocyte function
Change in transendothelial migration (TEM) in monocytes isolated from treated subjects
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Arterial inflammation
Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT)
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Arterial stiffness
Change in pulse wave velocity (PWV) (m/sec)
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Adverse events (AEs)/serious AEs (SAEs)
Incidence of AEs/SAEs
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Vital signs, height
in cm
Time frame: At screening (Day -63 to -1)
Vital signs, body weight
in kg
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Vital signs, blood pressure
in mmHg
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Vital signs, hear rate
in bpm
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Vital signs, body temperature
in °C
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Physical examination including review of all organ systems
Any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Electrocardiogram (ECG), PR (PQ)
12-lead ECG; PR (PQ) interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QRS
12-lead ECG; QRS interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QT
12-lead ECG; QT interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QTcF
12-lead ECG; QTcF interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
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