Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

October 19, 2020 updated by: GeNeuro Australia PTY Ltd

A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • Scientia Clinical Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Main Inclusion Criteria:

  • Healthy male volunteers
  • Negative urine drug screen
  • Have signed the informed consent.

Main Exclusion Criteria:

  • History of serious adverse reactions or hypersensitivity to any drug.
  • Use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. Permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cohort 1
GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
Active Comparator: Cohort 2
GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
Active Comparator: Cohort 3
GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
Active Comparator: Cohort 4
GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
Time Frame: 57 days
Serious Adverse Events (SAE), Adverse Events (AE)
57 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK): GNbAC1 serum concentrations over time
Time Frame: 57 days
GNbAC1 serum concentrations over time
57 days
Immunogenicity: Antibodies against GNbAC1 (ADA)
Time Frame: 57 days
Antibodies against GNbAC1 (ADA)
57 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GeNeuro Australia PTY Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2018

Primary Completion (Actual)

November 2, 2018

Study Completion (Actual)

November 2, 2018

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNC-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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