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

NCT ID: NCT02314442

Last Updated: 2015-12-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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Conditions

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Hypercholesterolemia

Keywords

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LDL-C RNAi therapeutic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ALN-PCSSC

Group Type ACTIVE_COMPARATOR

ALN-PCSSC

Intervention Type DRUG

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

Sterile Normal Saline (0.9% NaCl)

Group Type PLACEBO_COMPARATOR

Sterile Normal Saline (0.9% NaCl)

Intervention Type DRUG

calculated volume to match active comparator

Interventions

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ALN-PCSSC

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

Intervention Type DRUG

Sterile Normal Saline (0.9% NaCl)

calculated volume to match active comparator

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Medicines Company

INDUSTRY

Sponsor Role collaborator

Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Kauffman, MD

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Covance Clinical Research Unit

Leeds, , United Kingdom

Site Status

Richmond Pharmacology

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27959715 (View on PubMed)

Other Identifiers

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ALN-PCSSC-001

Identifier Type: -

Identifier Source: org_study_id