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Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT03574428
Recruitment Status : Active, not recruiting
First Posted : July 2, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
GeNeuro Australia PTY Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: GNbAC1 Other: GNbAC1 Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574428


Locations
Australia, New South Wales
Scientia Clinical Research Ltd
Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
GeNeuro Australia PTY Ltd

Responsible Party: GeNeuro Australia PTY Ltd
ClinicalTrials.gov Identifier: NCT03574428     History of Changes
Other Study ID Numbers: GNC-006
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases