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

Alnylam Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Hypercholesterolemia

Treatments

Drug: ALN-PCSSC

Drug: Sterile Normal Saline (0.9% NaCl)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02314442

ALN-PCSSC-001

Details and patient eligibility

About

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

Enrollment

70 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)