Trial | NCT03010046  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    27
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.
Study Started
Dec 31
2016
Primary Completion
Jun 30
2018
Study Completion
Jun 30
2018
Last Update
Aug 20
2020

Drug ANX005

Single ascending dose intravenous infusion

Drug IVIg

IVIg infusion in Cohorts 4b and 5b only. Randomized to ANX005 followed by IVIg or placebo followed by IVIg.

Drug Placebos

0.9% saline intravenous infusion

ANX005 Monotherapy Experimental

ANX005 intravenous infusion

ANX005 and IVIg Combination Therapy Experimental

ANX005 intravenous infusion in combination with intravenous immunoglobulin (IVIg)

Placebo Placebo Comparator

Placebo intravenous infusion

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.
No Results Posted