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ALN-4915

Phase 1

Healthy Volunteers | Small molecule | Other |Alnylam Pharmaceuticals, Inc.|Last Updated: May 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07535606A Study to Evaluate ALN-4915 in Adult Healthy VolunteersPHASE1 RECRUITING 44Mar 2, 2026Jul 31, 2027May 14, 20261 United Kingdom
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Study Endpoints
Primary Endpoints
Frequency of Adverse Events
Serious adverse events (SAEs) after signing of ICF up to Month 12; nonserious AEs after first dose of study drug up to Month 12
Secondary Endpoints
Change from Baseline Inflammatory Markers in Plasma
Baseline up to Month 9
Concentration of ALN-4915 in Plasma
Predose up to Day 3
Concentration of ALN-4915 in Urine
Predose up to Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALN-4915EXPERIMENTALParticipants will be administered a single dose of ALN-4195.
PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of placebo.
Interventions
NameTypeDescription
ALN-4915DRUGALN-4915 will be administered subcutaneously (SC)
PlaceboDRUGPlacebo will be administered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is willing and able to complete all study assessments Exclusion Criteria: * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>upper limit of normal (ULN) * Has total bilirubin \>ULN * Has no history of invasive infection by an encapsulated organism * H...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07535606primaryCompletionDate: changed
LOWMay 24, 2026NCT07535606studyFirstPostDate: changed
LOWMay 21, 2026NCT07535606NEW_TRIAL: changed
LOWMay 21, 2026NCT07535606NEW_TRIAL: changed