Single Dose Study of ANX005 in Healthy Volunteers

• Status: Terminated
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Annexon, Inc.
• Treatments: Immunoglobulins, Intravenous

Criteria

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.