Single Dose Study of ANX005 in Healthy Volunteers

A Phase 1, Randomized, Placebo-controlled, Double Blind, Single, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX005 Monotherapy and ANX005 in Combination With IVIg in Healthy Volunteers

This is a single-center, randomized, double-blind, placebo-controlled, ascending, single-infusion, sequential group study. Single, ascending doses will be administered to approximately 64 subjects, with an option for 1 additional multi-dose cohort in approximately 8 subjects. The primary objective is to evaluate the safety of ANX005 administered as an intravenous infusion as a single agent and in combination with intravenous immunoglobulin (IVIg). The optional multi-dose cohort will evaluate either additional subjects at the maximum tolerated dose or ANX005 administered as 2 infusions.

Inclusion Criteria:

• Male and females 18 years and older
• Females must be postmenopausal, surgically sterilized, or willing and able to use 2 methods of contraception throughout the study and for 1 month after the final study visit
• Willing and able to undergo vaccination if not vaccinated recently

Exclusion Criteria:

• History of any autoimmune disease, meningitis, septicemia or pneumonia
• History of hypercoagulable diseases, hyperviscosity, thrombosis, renal dysfunction or acute renal failure
• Known genetic deficiencies of the complement cascade system
• History of conditions whose symptoms and effects could alter protein catabolism or IgG utilization, e.g. protein-losing enteropathies or nephrotic syndrome
• Body weight less than 50 kg or greater than 100 kg
• Hypersensitivity or allergic reactions to any excipients in the ANX005 drug product
• (Cohorts 4b and 5b) Known selective IgA deficiency or presence of antibodies to IgA at screening
• (Cohorts 4b and 5b) Prior reaction or hypersensitivity to blood products, including IVIg or any of the excipients in IVIg.