Healthy
Conditions
Keywords
Healthy
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.
Interventions
BIOLOGICALANX105
Participants will receive single-ascending doses of ANX105 administered by IV infusion.
DRUGPlacebo
Participants will receive matching placebo administered by IV infusion.
Sponsors
Annexon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Placebo-controlled single ascending dose study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced Treatment-Emergent Adverse Events | Up to Week 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum | Baseline, Week 7 | Blood samples will be obtained to determine the amount of C1q. |
| Amount of C1q in Cerebrospinal fluid (CSF) | Up to Week 7 | CSF samples will be obtained to determine the amount of C1q. |
| Serum Concentrations of ANX105 | Up to Week 7 | Blood samples will be obtained to determine serum concentrations of ANX105. |
| Amount of Serum Total Hemolytic Complement (CH50) | Up to Week 7 | Blood samples will be obtained to determine the amount of CH50. |
| Area Under the ANX105 Serum Concentration-Time Curve (AUC) | Up to Week 7 | Blood samples will be obtained to determine the AUC of ANX105. |
| CSF Concentrations of ANX105 | Up to Week 7 | CSF samples will be obtained to determine CSF concentrations of ANX105. |
| Maximum Observed Serum Concentration (Cmax) of ANX105 | Up to Week 7 | Blood samples will be obtained to determine the Cmax of ANX105. |
Countries
Netherlands
Outcome results
None listed