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Completed

NCT Number: NCT03574428

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Scientia Clinical Research Ltd

Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GNbAC1

Drug

Monoclonal Antibody infused i.v.

GNbAC1 Placebo

Other

Equivalent to GNbAC1 Buffer

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pharmacokinetic (PK): GNbAC1 serum concentrations over time

    Time frame: 57 days

    GNbAC1 serum concentrations over time

  2. Immunogenicity: Antibodies against GNbAC1 (ADA)

    Time frame: 57 days

    Antibodies against GNbAC1 (ADA)

Sponsors and collaborators

Lead sponsor

GeNeuro Australia PTY Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2018
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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