Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
NCT ID: NCT01437059
Last Updated: 2012-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2011-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ALN-PCS02
ALN-PCS02
Dose levels between 15 and 400 μg/kg by intravenous (IV) infusion
Sterile Normal Saline (0.9% NaCl)
Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator
Interventions
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ALN-PCS02
Dose levels between 15 and 400 μg/kg by intravenous (IV) infusion
Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Simon, MD
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Site
Leeds, , United Kingdom
Clinical Site
London, , United Kingdom
Countries
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References
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Fitzgerald K, Frank-Kamenetsky M, Shulga-Morskaya S, Liebow A, Bettencourt BR, Sutherland JE, Hutabarat RM, Clausen VA, Karsten V, Cehelsky J, Nochur SV, Kotelianski V, Horton J, Mant T, Chiesa J, Ritter J, Munisamy M, Vaishnaw AK, Gollob JA, Simon A. Effect of an RNA interference drug on the synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9) and the concentration of serum LDL cholesterol in healthy volunteers: a randomised, single-blind, placebo-controlled, phase 1 trial. Lancet. 2014 Jan 4;383(9911):60-68. doi: 10.1016/S0140-6736(13)61914-5. Epub 2013 Oct 3.
Other Identifiers
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ALN-PCS02-001
Identifier Type: -
Identifier Source: org_study_id