Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Athera Biotechnologies

Status and phase

Terminated

Phase 2

Conditions

Arterial Inflammation

Cardiovascular Diseases

Treatments

Drug: Placebo

Drug: PC-mAb

Study type

Interventional

Funder types

Industry

Identifiers

NCT03320265

ATH3G10-005

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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