Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
Phase 1
Completed
- Conditions
- Elevated LDL-Cholesterol (LDL-C)
- Interventions
- Drug: Sterile Normal Saline (0.9% NaCl)
- Registration Number
- NCT01437059
- Lead Sponsor
- Alnylam Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALN-PCS02 ALN-PCS02 - Sterile Normal Saline (0.9% NaCl) Sterile Normal Saline (0.9% NaCl) -
- Primary Outcome Measures
Name Time Method The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation. Up to 28 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) of ALN-PCS02 (Cmax, tmax, t1/2, AUC0-last, CL). Up to 180 days Effect of ALN-PCS02 on Circulating PCSK9 Levels (Determination of % Lowering of PCSK9 to pretreatment/Baseline PCSK9 Level). Up to 28 days Effect of ALN-PCS02 on Circulating LDL-c Levels (Determination of % Lowering of LDL-c to pretreatment/Baseline LDL-c Level). Up to 28 days
Trial Locations
- Locations (1)
Clinical Site
🇬🇧London, United Kingdom