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Trial record 1 of 5 for: ALN-PCSsc

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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT02314442

First Posted: December 11, 2014

Last Update Posted: December 17, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

The Medicines Company

Information provided by (Responsible Party):

Alnylam Pharmaceuticals

Purpose

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

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ALN-PCSSC Drug: Sterile Normal Saline (0.9% NaCl)	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Alnylam Pharmaceuticals:

Primary Outcome Measures:

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 Outcome Measures:

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 ]
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 ]
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 ]


Enrollment:	70
Study Start Date:	December 2014
Study Completion Date:	November 2015
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ALN-PCSSC	Drug: ALN-PCSSC Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection
Placebo Comparator: Sterile Normal Saline (0.9% NaCl)	Drug: Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314442

Locations


United Kingdom
Covance Clinical Research Unit
Leeds, United Kingdom
Richmond Pharmacology
London, United Kingdom

Sponsors and Collaborators

Alnylam Pharmaceuticals

The Medicines Company

Investigators


Study Director:	Robert Kauffman, MD	Alnylam Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fitzgerald K, White S, Borodovsky A, Bettencourt BR, Strahs A, Clausen V, Wijngaard P, Horton JD, Taubel J, Brooks A, Fernando C, Kauffman RS, Kallend D, Vaishnaw A, Simon A. A Highly Durable RNAi Therapeutic Inhibitor of PCSK9. N Engl J Med. 2017 Jan 5;376(1):41-51. doi: 10.1056/NEJMoa1609243. Epub 2016 Nov 13.


Responsible Party:	Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02314442 History of Changes
Other Study ID Numbers:	ALN-PCSSC-001
First Submitted:	December 5, 2014
First Posted:	December 11, 2014
Last Update Posted:	December 17, 2015
Last Verified:	December 2015

Keywords provided by Alnylam Pharmaceuticals:


LDL-C RNAi therapeutic

Additional relevant MeSH terms:


Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

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