This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Annexon Investigational Site 02
Groningen, Netherlands
Annexon Investigational Site 01
Leiden, Netherlands
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Time frame: Up to Week 7
Amount of Serum Total Hemolytic Complement (CH50)
Blood samples will be obtained to determine the amount of CH50.
Time frame: Up to Week 7
Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum
Blood samples will be obtained to determine the amount of C1q.
Time frame: Baseline, Week 7
Amount of C1q in Cerebrospinal fluid (CSF)
CSF samples will be obtained to determine the amount of C1q.
Time frame: Up to Week 7
Serum Concentrations of ANX105
Blood samples will be obtained to determine serum concentrations of ANX105.
Time frame: Up to Week 7
Maximum Observed Serum Concentration (Cmax) of ANX105
Blood samples will be obtained to determine the Cmax of ANX105.
Time frame: Up to Week 7
Area Under the ANX105 Serum Concentration-Time Curve (AUC)
Blood samples will be obtained to determine the AUC of ANX105.
Time frame: Up to Week 7
CSF Concentrations of ANX105
CSF samples will be obtained to determine CSF concentrations of ANX105.
Time frame: Up to Week 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.