A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alnylam Pharmaceuticals
• Collaborator: The Medicines Company

Criteria

Inclusion Criteria:

• Adequate complete blood counts, liver and renal function

• Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization

• Male subjects agree to use appropriate contraception

• Willing to provide written informed consent and willing to comply with study requirements.

• Non-smokers and non-nicotine users for at least 90 days before screening

• On stable statin co-medication [for designated multiple dose cohorts only]

Exclusion Criteria:

• Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk

• Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study

• History of multiple drug allergies or intolerance to subcutaneous injection

• Received any medication or nutraceutical to alter serum lipids within 30 days before screening (non-statin cohorts only)