MedTrace Logo

Single Dose Study of ANX005 in Healthy Volunteers

NCT03010046 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-08-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Annexon, Inc.

    lead INDUSTRY

Principal Investigators

  • Sandy Calman, MD · Annexon Medical Monitor

  • Jason Lickliter, MBBS PhD · Nucleus Network Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010046 on ClinicalTrials.gov