Single Dose Study of ANX005 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Safety and Tolerability in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ANX005 Monotherapy

ANX005 intravenous infusion

Group Type EXPERIMENTAL

ANX005

Intervention Type DRUG

Single ascending dose intravenous infusion

ANX005 and IVIg Combination Therapy

ANX005 intravenous infusion in combination with intravenous immunoglobulin (IVIg)

Group Type EXPERIMENTAL

ANX005

Intervention Type DRUG

Single ascending dose intravenous infusion

IVIg

Intervention Type DRUG

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

Placebo

Placebo intravenous infusion

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

0.9% saline intravenous infusion

Interventions

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ANX005

Single ascending dose intravenous infusion

Intervention Type DRUG

IVIg

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

Intervention Type DRUG

Placebos

0.9% saline intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes