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Single Dose Study of ANX005 in Healthy Volunteers | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT03010046•Annexon, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Nucleus Network

Melbourne, Victoria, Australia

Key Dates

Start Date

December 1, 2016

Primary Completion Date

June 1, 2018

Completion Date

June 1, 2018

Last Updated

August 20, 2020

Enrollment

ACTUAL participants

Conditions

Safety and Tolerability in Healthy Volunteers

Interventions

ANX005

DRUG

IVIg

DRUG

Placebos

DRUG

A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects

NCT03672604

Safety and Tolerability in Healthy Volunteers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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