Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)

Alnylam Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Elevated LDL-Cholesterol (LDL-C)

Treatments

Drug: ALN-PCS02

Drug: Sterile Normal Saline (0.9% NaCl)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01437059

ALN-PCS02-001

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol (LDL-C).

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Elevated LDL-C of >3.0 mmol/L and <5.7 mmol/L
Fasting triglyceride concentration ≤2.8 mmol/L
Body weight >60.0 kg; body mass index (BMI) between 19.00 kg/m2 and <35.00 kg/m2
Adequate blood counts, liver and renal function
May not received any lipid lowering drug/agent within the 30 days prior to the screening
Non-smokers for at least 3 months
Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control
Males agree to use appropriate contraception
Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent

Exclusion criteria

Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
Multiple drug allergies or know sensitivity to oligonucleotide
History of drug abuse and/or alcohol abuse
Receiving an investigational agent within 3 months prior to study drug administration
Subjects with safety laboratory test results deemed clinical significant by the Investigator;
Received prescription drugs within 4 weeks of first dosing
Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration;
Received megadose vitamin therapy or dietary supplements within 4 weeks prior to screening
Subjects who have used prescription drugs within 4 weeks of first dosing
Considered unfit for the study by the Principal Investigator
Employee or family member of the sponsor or the clinical study site personnel