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Dose Study of ANX1502 in Healthy Volunteers

NCT ID: NCT05521269

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-11-19

Brief Summary

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This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.

Detailed Description

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Conditions

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Healthy

Keywords

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healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ANX1502 SAD

Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.

Group Type EXPERIMENTAL

ANX1502

Intervention Type DRUG

ANX1502 is a prodrug of ANX1439.

Placebo

Intervention Type DRUG

Placebo comparator.

ANX1502 MAD

Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.

Group Type EXPERIMENTAL

ANX1502

Intervention Type DRUG

ANX1502 is a prodrug of ANX1439.

Placebo

Intervention Type DRUG

Placebo comparator.

Interventions

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ANX1502

ANX1502 is a prodrug of ANX1439.

Intervention Type DRUG

Placebo

Placebo comparator.

Intervention Type DRUG

Eligibility Criteria

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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 laboratory tests.
* MAD cohorts only: Documented history of vaccinations within 5 years of Screening or willing to undergo vaccinations prior to Screening against encapsulated bacterial pathogens.

Exclusion Criteria

* History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, malabsorption syndrome, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data. Exceptions can be made for individuals with childhood or remote disorders that are no longer active.
* History of any autoimmune disease
* History of meningitis or septicemia
* Clinically significant infection within 30 days prior to study drug administration that required medical intervention
* Known genetic deficiencies of the complement cascade system or immunodeficiency.
* Clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
* Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions .
* History of prior other malignancy that could affect compliance with the protocol or interpretation of results
* Has clinically significant laboratory abnormalities or abnormal ECG
* History of splenectomy.
* Antinuclear antibodies titer ≥1:160 at Screening.
* Has donated blood or plasma within 30 days prior to Screening or had a loss of whole blood of more than 500 milliliter (mL) within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Annexon, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olga Bandman

Role: STUDY_DIRECTOR

Annexon, Inc.

Locations

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Annexon Investigational Site 01

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2022-000594-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ANX1502-NHV-01

Identifier Type: -

Identifier Source: org_study_id