Skip to main content
OpenTrials
Completed

NCT Number: NCT02314442

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Leeds, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adequate complete blood counts, liver and renal function
  • Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization
  • Male subjects agree to use appropriate contraception
  • Willing to provide written informed consent and willing to comply with study requirements.
  • Non-smokers and non-nicotine users for at least 90 days before screening
  • On stable statin co-medication [for designated multiple dose cohorts only]

Exclusion criteria

  • Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
  • Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
  • History of multiple drug allergies or intolerance to subcutaneous injection
  • Received any medication or nutraceutical to alter serum lipids within 30 days before screening (non-statin cohorts only)

Treatment and study plan

ALN-PCSSC

Drug

Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection

Sterile Normal Saline (0.9% NaCl)

Drug

calculated volume to match active comparator

Primary outcomes

  1. The safety of ALN-PCSSC evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation

    Time frame: Part 1 (SAD phase): up to 180 days post dose; Part 2 (MD) phase: up to 180 days post final dose

Secondary outcomes

  1. The pharmacokinetics (PK) of ALN-PCSSC (Cmax, tmax, AUC, t1/2)

    Time frame: Part 1 (SAD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 42, 56 days post-dose; Part 2 (MD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 29, 35, 42, 56, 84 days post-dose

  2. The effect of ALN-PCSSC on serum levels of LDL-C

    Time frame: Through the sooner of final follow up visit or 180 days post final dose

  3. The effect of ALN-PCSSC on plasma levels of PCSK9

    Time frame: Through the sooner of final follow up visit or 180 days post final dose

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Collaborators

  • The Medicines Company

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2014
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.