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

NCT01437059 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-10-12

No results posted yet for this study

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).

Conditions

  • Elevated LDL-Cholesterol (LDL-C)

Interventions

DRUG

ALN-PCS02

Dose levels between 15 and 400 μg/kg by intravenous (IV) infusion

DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Sponsors & Collaborators

Principal Investigators

  • Amy Simon, MD · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-03-31
Completion
2012-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437059 on ClinicalTrials.gov