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OpenTrials
Completed

NCT Number: NCT05521269

Dose Study of ANX1502 in Healthy Volunteers

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Annexon Investigational Site 01

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Key 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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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.

Treatment and study plan

ANX1502

Drug

ANX1502 is a prodrug of ANX1439.

Placebo

Drug

Placebo comparator.

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502

    Time frame: Day 1 (after dosing) through Day 29

Secondary outcomes

  1. Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502

    Time frame: Predose up Day 29

  2. Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502

    Time frame: Predose up Day 29

  3. Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502

    Time frame: Predose up to Day 29

  4. Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502

    Time frame: Predose up Day 29

  5. Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502

    Time frame: Predose up to Day 29

Sponsors and collaborators

Lead sponsor

Annexon, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX1502 in Normal Healthy Volunteer

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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