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ANX105

Phase 1

Healthy | Monoclonal antibody | Other |Annexon, Inc.|Last Updated: Aug 19, 2024

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 Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05288881Single Ascending Dose Study of ANX105PHASE1 COMPLETED 23 — — Feb 28, 2022Jun 19, 2023Aug 19, 20242 Netherlands
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Up to Week 7
Secondary Endpoints
Amount of Serum Total Hemolytic Complement (CH50)
Up to Week 7
Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum
Baseline, Week 7
Amount of C1q in Cerebrospinal fluid (CSF)
Up to Week 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ANX105EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ANX105BIOLOGICALParticipants will receive single-ascending doses of ANX105 administered by IV infusion.
PlaceboDRUGParticipants will receive matching placebo administered by IV infusion.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Key Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. * Have been fully vaccinated with SARS-CoV-2 vaccination according to local guidelines within 14 days prior to Day -1. * Document...

Countries:Netherlands
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