NCT03010046

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2017-01-04
• Last updated: 2020-08-20

Locations

1 site across 1 country: Australia