Status:
COMPLETED
Single Ascending Dose Study of ANX105
Lead Sponsor:
Annexon, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05288881
Start Date
February 28 2022
End Date
June 19 2023
Last Update
August 19 2024
Active Locations (2)
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1
Annexon Investigational Site 02
Groningen, Netherlands
2
Annexon Investigational Site 01
Leiden, Netherlands