Single Ascending Dose Study of ANX105

Annexon

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Biological: ANX105

Study type

Interventional

Funder types

Industry

Identifiers

NCT05288881

2021-005510-33 (EudraCT Number)

ANX105-NHV-01

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.