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Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE July 2, 2018
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE May 8, 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03574428 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • Pharmacokinetic (PK): GNbAC1 serum concentrations over time [ Time Frame: 57 days ]
    GNbAC1 serum concentrations over time
  • Immunogenicity: Antibodies against GNbAC1 (ADA) [ Time Frame: 57 days ]
    Antibodies against GNbAC1 (ADA)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Official Title  ICMJE A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: GNbAC1
    Monoclonal Antibody infused i.v.
  • Other: GNbAC1 Placebo
    Equivalent to GNbAC1 Buffer
Study Arms
  • Active Comparator: Cohort 1
    GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
    Interventions:
    • Drug: GNbAC1
    • Other: GNbAC1 Placebo
  • Active Comparator: Cohort 2
    GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
    Interventions:
    • Drug: GNbAC1
    • Other: GNbAC1 Placebo
  • Active Comparator: Cohort 3
    GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
    Interventions:
    • Drug: GNbAC1
    • Other: GNbAC1 Placebo
  • Active Comparator: Cohort 4
    GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
    Interventions:
    • Drug: GNbAC1
    • Other: GNbAC1 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03574428
Other Study ID Numbers  ICMJE GNC-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party GeNeuro Australia PTY Ltd
Study Sponsor  ICMJE GeNeuro Australia PTY Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GeNeuro Australia PTY Ltd
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP