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ALN-TTRSC02

Phase 1

Transthyretin-mediated Amyloidosis (ATTR Amyloidosis) | Small molecule | Rare Disease |Alnylam Pharmaceuticals, Inc.|Last Updated: Sep 21, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

ALN-TTRSC02 · 1 trial · 1 indication

Phase 1 1
NCT02797847A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy SubjectsTransthyretin-mediated Amyloidosis (ATTR Amyloidosis)
COMPLETED80 Analytics
PHASE1COMPLETED
A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects
Transthyretin-mediated Amyloidosis (ATTR Amyloidosis)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety of ALN-TTRSC02, evaluated by the proportion of subjects experiencing adverse events (AEs)
Day 1 through to Day 314

Secondary Endpoints

Profile of pharmacokinetics (PK) of ALN-TTRSC02
Day 1 through to Day 3
Effect of ALN-TTRSC02 on serum TTR levels as measured by reduction from baseline in serum TTR
Day 1 through to Day 314
Effect of ALN-TTRSC02 on serum Vitamin A levels as measured by reduction from baseline in serum Vitamin A
Screening through to Day 314
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-TTRSC02ACTIVE_COMPARATOR -
Sterile normal saline 0.9% for SC administrationPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ALN-TTRSC02DRUGAscending doses of ALN-TTRSC02 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 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female subjects, age 18 to 65 years, inclusive. * Body mass index (BMI) ≥18.0 kg/m2 and ≤30 kg/m2 assessed at Screening. * No clinically significant health concerns, as determined by medical history and physical examination, in the opinion of the Investigator. * Women...

Countries:United Kingdom
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Frequently asked questions about ALN-TTRSC02

What is ALN-TTRSC used for?

ALN-TTRSC is an investigational drug being developed for transthyretin-mediated amyloidosis (ATTR amyloidosis), a rare disease. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

Who makes ALN-TTRSC?

ALN-TTRSC is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock ticker is ALNY. The drug is currently in Phase 1 clinical trials for transthyretin-mediated amyloidosis.

What phase is ALN-TTRSC in?

ALN-TTRSC is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety and tolerability.

What clinical trials is ALN-TTRSC in?

ALN-TTRSC has been studied in three completed Phase 1 clinical trials. These include NCT01814839, NCT02797847, and NCT05661916. All trials were conducted in the United Kingdom and enrolled healthy volunteers aged 18 years and older.

Is ALN-TTRSC the same as revusiran?

ALN-TTRSC is also known as revusiran. In clinical trial NCT01814839, the drug is referred to as ALN-TTRSC (Revusiran). The drug is being developed for transthyretin-mediated amyloidosis.