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ANX105

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

ANX105 · 1 trial · 1 indication

Phase 1 1
NCT05288881Single Ascending Dose Study of ANX105Healthy
COMPLETED23 Analytics
PHASE1COMPLETED
Single Ascending Dose Study of ANX105
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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 to 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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Frequently asked questions about ANX105

What is ANX105?

ANX105 is an investigational monoclonal antibody being developed by Annexon, Inc. It is currently in Phase 1 clinical development. The drug has been studied in a single ascending dose trial in healthy volunteers, with the trial completed.

What is ANX105 used for?

ANX105 is being studied for use in healthy volunteers as part of early clinical development. The completed Phase 1 trial evaluated single ascending doses of the drug in healthy participants to assess safety and tolerability.

Who makes ANX105?

ANX105 is being developed by Annexon, Inc., a biopharmaceutical company. The company's stock is listed under the ticker symbol ANNX on the stock market.

What phase is ANX105 in?

ANX105 is in Phase 1 clinical development. The Phase 1 trial, which was a single ascending dose study, has been completed. The drug is still in the investigational stage and has not been approved for any use.

What clinical trials is ANX105 in?

ANX105 has one completed clinical trial, identified as NCT05288881. This was a Phase 1, single ascending dose study conducted in the Netherlands with 23 healthy participants. The trial was randomized, double-blind, and placebo-controlled.

Is ANX105 the same as other drugs?

ANX105 is not known to have alternative names. It is a distinct investigational monoclonal antibody being developed by Annexon, Inc. for potential therapeutic use.