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ANX1502

Phase 1

Undisclosed | Small molecule | Other |Annexon, Inc.|Trials Updated: Dec 27, 2024

ANX1502 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2022

ANX1502 target and mechanism

Molecular targetC1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

ANX1502 clinical trials

ANX1502 · 1 trial · 1 indication

Phase 1 1
NCT05521269Dose Study of ANX1502 in Healthy VolunteersHealthy
COMPLETED135 Analytics
PHASE1COMPLETED
Dose Study of ANX1502 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
Day 1 (after dosing) through Day 29

Secondary Endpoints

Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502
Predose up Day 29
Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Predose up Day 29
Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Predose up to Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ANX1502 SADEXPERIMENTALParticipants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
ANX1502 MADEXPERIMENTALParticipants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.

Interventions

NameTypeDescription
ANX1502DRUGANX1502 is a prodrug of ANX1439.
PlaceboDRUGPlacebo comparator.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laborato...

Countries:Netherlands
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Frequently asked questions about ANX1502

What is ANX1502?

ANX1502 is a small molecule C1 inhibitor being developed by Annexon, Inc. It is an investigational drug that has been studied in a Phase 1 clinical trial in healthy volunteers. Annexon trades on the Nasdaq under the ticker ANNX.

What does ANX1502 target?

ANX1502 targets C1, a component of the complement system, and acts as a C1 inhibitor. By inhibiting C1, the drug is designed to modulate complement activity. The specific disease indications being pursued for ANX1502 have not been disclosed.

Who makes ANX1502?

ANX1502 is being developed by Annexon, Inc., a biopharmaceutical company listed on the Nasdaq under the ticker symbol ANNX. Annexon is the sponsor of the clinical program evaluating ANX1502.

What phase is ANX1502 in?

ANX1502 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for the asset.

What clinical trials is ANX1502 in?

ANX1502 has been evaluated in one completed Phase 1 trial, NCT05521269, titled Dose Study of ANX1502 in Healthy Volunteers. The trial enrolled 135 participants in the Netherlands, was randomized, double-blind, and controlled, and included adults 18 years and older.