Overview

Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Status:
Terminated
Trial end date:
2018-07-03
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Athera Biotechnologies AB
Treatments:
Antibodies, Monoclonal
Criteria
Major inclusion criterion:

- Lp(a) above 50 mg/dL at screening

Major exclusion criteria:

- Medical history of myocardial infarction (MI) or stroke within 12 months of screening

- Ongoing or paroxysmal atrial fibrillation

- Clinically overt heart failure

- Hypertension defined as ≥180/100 mmHg

- Diabetes mellitus

- Systemic autoimmune diseases requiring treatment

- Cancer, excluding basal cell carcinoma, within the last five years