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ARO-CFB

Phase 1

IgA Nephropathy | Small molecule | Nephrology |Arrowhead Pharmaceuticals, Inc.|Last Updated: May 20, 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-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06209177Study of ARO-CFB in Adult Healthy VolunteersPHASE1 COMPLETED 49Apr 5, 2024Mar 6, 2026May 20, 20261 New Zealand
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
up to Day 169 (End of Study [EOS])
Secondary Endpoints
Pharmacokinetics (PK) of ARO-CFB: Maximum Observed Plasma Concentration (Cmax)
up to 48 hours postdose
PK of ARO-CFB: Time to Maximum Observed Plasma Concentration (Tmax)
up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
up to 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARO-CFB (Healthy Volunteers)EXPERIMENTAL1 or 2 doses of ARO-CFB by subcutaneous (sc) injection
Placebo (Healthy Volunteers)EXPERIMENTALplacebo calculated volume to match active treatment by sc injection
Interventions
NameTypeDescription
ARO-CFBDRUGARO-CFB for sc injection
PlaceboDRUGsterile normal saline (0.9% NaCl for sc injection)
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Willing to provide written informed consent and to comply with study requirements * Female participants must be non-pregnant/non-lactating * Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. IgAN participants must have been vacc...

Countries:New Zealand
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06209177Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT06209177studyFirstPostDate: changed