Single Dose Study of ANX005 in Healthy Volunteers

Safety and Tolerability in Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03010046
• Other study ID #: ANX005-CP01
• Status: Terminated
• Phase: Phase 1
• Start date: December 2016
• Est. completion date: June 2018

Study information

• Verified date: August 2020
• Source: Annexon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Safety and Tolerability in Healthy Volunteers

Intervention

Drug:
• ANX005
Single ascending dose intravenous infusion
• IVIg
IVIg infusion in Cohorts 4b and 5b only. Randomized to ANX005 followed by IVIg or placebo followed by IVIg.
• Placebos
0.9% saline intravenous infusion

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Annexon, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore relationship of AUC with PD responses in serum		Day 43
Other	Explore relationship of AUC with PD responses in CSF		Day 43
Other	Explore relationship of half-life with PD responses in serum		Day 43
Other	Explore relationship of half-life with PD responses in CSF		Day 43
Primary	Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03	Safety is assessed throughout the study. Day 43 is the last visit.	Day 43
Secondary	Peak plasma concentration		Day 43
Secondary	Determine effective dose of ANX005	Percent of subjects with a biologic response, defined as a reduction of serum CH50 percent change from baseline at 21 and 28 days after the first ANX005 infusion	Day 43
Secondary	Area under the plasma concentration versus time curve (AUC)		Day 43
Secondary	Terminal half-life		Day 43