NCT02314442

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

A Phase 1, Randomized, Single Blind, Placebo Controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN PCSSC in Subjects With Elevated Low Density Lipoprotein Cholesterol

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ALN-PCSSC	Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection
DRUG	Sterile Normal Saline (0.9% NaCl)	calculated volume to match active comparator

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-05-01
• Completion: 2015-11-01
• First posted: 2014-12-11
• Last updated: 2015-12-17

Locations

2 sites across 1 country: United Kingdom