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OpenTrials
Completed

NCT Number: NCT05288881

Single Ascending Dose Study of ANX105

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Annexon Investigational Site 02, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

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

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.
  • Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.

Key Exclusion Criteria:

  • Clinically significant infection within 30 days prior to Day -1 that required medical intervention.
  • Significant allergies to humanized monoclonal antibodies.
  • Use of immunosuppressants including high-dose systemic corticosteroids within 30 days prior to Day -1.
  • Antinuclear antibodies (ANA) titer ≥1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) at Screening.
  • Have poor venous access limiting phlebotomy.
  • Donation or loss of > 500 milliliter whole blood within 30 days prior to Day 1 or donation of plasma within 14 days prior to Day -1.
  • Hospitalization during the 4 weeks prior to Screening.

Treatment and study plan

ANX105

Biological

Participants will receive single-ascending doses of ANX105 administered by IV infusion.

Placebo

Drug

Participants will receive matching placebo administered by IV infusion.

Primary outcomes

  1. Number of Participants Who Experienced Treatment-Emergent Adverse Events

    Time frame: Up to Week 7

Secondary outcomes

  1. Amount of Serum Total Hemolytic Complement (CH50)

    Time frame: Up to Week 7

    Blood samples will be obtained to determine the amount of CH50.

  2. Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum

    Time frame: Baseline, Week 7

    Blood samples will be obtained to determine the amount of C1q.

  3. Amount of C1q in Cerebrospinal fluid (CSF)

    Time frame: Up to Week 7

    CSF samples will be obtained to determine the amount of C1q.

  4. Serum Concentrations of ANX105

    Time frame: Up to Week 7

    Blood samples will be obtained to determine serum concentrations of ANX105.

  5. Maximum Observed Serum Concentration (Cmax) of ANX105

    Time frame: Up to Week 7

    Blood samples will be obtained to determine the Cmax of ANX105.

  6. Area Under the ANX105 Serum Concentration-Time Curve (AUC)

    Time frame: Up to Week 7

    Blood samples will be obtained to determine the AUC of ANX105.

  7. CSF Concentrations of ANX105

    Time frame: Up to Week 7

    CSF samples will be obtained to determine CSF concentrations of ANX105.

Sponsors and collaborators

Lead sponsor

Annexon, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
Aug 19, 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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