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ALN-PCSSC

Phase 1

Hypercholesterolemia | Small molecule | Metabolic |Alnylam Pharmaceuticals, Inc.|Last Updated: Dec 17, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

ALN-PCSSC · 1 trial · 1 indication

Phase 1 1
NCT02314442A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)Hypercholesterolemia
COMPLETED70 Analytics
PHASE1COMPLETED
A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

The pharmacokinetics (PK) of ALN-PCSSC (Cmax, tmax, AUC, t1/2)
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
Through the sooner of final follow up visit or 180 days post final dose
The effect of ALN-PCSSC on plasma levels of PCSK9
Through the sooner of final follow up visit or 180 days post final dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-PCSSCACTIVE_COMPARATOR -
Sterile Normal Saline (0.9% NaCl)PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ALN-PCSSCDRUGSingle or multiple doses of ALN-PCSSC by subcutaneous (sc) injection
Sterile Normal Saline (0.9% NaCl)DRUGcalculated volume to match active comparator
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 con...

Countries:United Kingdom
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Frequently asked questions about ALN-PCSSC

What is ALN-PCSSC used for?

ALN-PCSSC is an investigational drug being studied for the treatment of hypercholesterolemia, a condition characterized by elevated levels of low-density lipoprotein cholesterol (LDL-C). It is currently in Phase 1 clinical development and has not been approved for any use.

Who makes ALN-PCSSC?

ALN-PCSSC is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALNY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is ALN-PCSSC in?

ALN-PCSSC is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to assess its safety and tolerability in subjects with elevated LDL-C.

What clinical trials is ALN-PCSSC in?

ALN-PCSSC has one completed Phase 1 clinical trial registered as NCT02314442. This study, titled 'A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C),' enrolled 70 participants in the United Kingdom and included healthy volunteers.

Is ALN-PCSSC the same as any other drug?

No alternative names for ALN-PCSSC have been reported. The drug is identified solely by its code name ALN-PCSSC in clinical trial registrations and scientific literature. It is distinct from other investigational agents in Alnylam's pipeline.