Single Dose Study of ANX005 in Healthy Volunteers

Annexon

Status and phase: Terminated; Phase 1

Conditions: Safety and Tolerability in Healthy Volunteers

Treatments: Drug: ANX005; Drug: IVIg; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT03010046

ANX005-CP01

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 3 patient groups, including a placebo group

ANX005 Monotherapy

Experimental group

Description:

ANX005 intravenous infusion

Treatment:

Drug: ANX005

ANX005 and IVIg Combination Therapy

Experimental group

Description:

ANX005 intravenous infusion in combination with intravenous immunoglobulin (IVIg)

Treatment:

Drug: IVIg

Drug: ANX005

Placebo

Placebo Comparator group

Description:

Placebo intravenous infusion

Treatment:

Drug: Placebos