Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574428
• Other study ID #: GNC-006
• Status: Completed
• Phase: Phase 1
• Start date: May 8, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: May 2019
• Source: GeNeuro SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• GNbAC1
Monoclonal Antibody infused i.v.

Other:
• GNbAC1 Placebo
Equivalent to GNbAC1 Buffer

Locations

Country	Name	City	State
Australia	Scientia Clinical Research Ltd	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GeNeuro Australia PTY Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)	Serious Adverse Events (SAE), Adverse Events (AE)	57 days
Secondary	Pharmacokinetic (PK): GNbAC1 serum concentrations over time	GNbAC1 serum concentrations over time	57 days
Secondary	Immunogenicity: Antibodies against GNbAC1 (ADA)	Antibodies against GNbAC1 (ADA)	57 days