Back to resultsSingle Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
GNbAC1
GNbAC1 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Temelimab
Eligibility 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.
Sites / Locations
- Scientia Clinical Research Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
Outcomes
Primary Outcome Measures
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
Serious Adverse Events (SAE), Adverse Events (AE)
Secondary Outcome Measures
Pharmacokinetic (PK): GNbAC1 serum concentrations over time
GNbAC1 serum concentrations over time
Immunogenicity: Antibodies against GNbAC1 (ADA)
Antibodies against GNbAC1 (ADA)
Full Information
NCT ID
NCT03574428
First Posted
May 16, 2018
Last Updated
October 19, 2020
Sponsor
GeNeuro Australia PTY Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03574428
Brief Title
Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Official Title
A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeNeuro Australia PTY Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Temelimab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
Arm Title
Cohort 3
Arm Type
Active Comparator
Arm Description
GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
Arm Title
Cohort 4
Arm Type
Active Comparator
Arm Description
GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
Intervention Type
Drug
Intervention Name(s)
GNbAC1
Intervention Description
Monoclonal Antibody infused i.v.
Intervention Type
Other
Intervention Name(s)
GNbAC1 Placebo
Intervention Description
Equivalent to GNbAC1 Buffer
Primary Outcome Measure Information:
Title
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
Description
Serious Adverse Events (SAE), Adverse Events (AE)
Time Frame
57 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK): GNbAC1 serum concentrations over time
Description
GNbAC1 serum concentrations over time
Time Frame
57 days
Title
Immunogenicity: Antibodies against GNbAC1 (ADA)
Description
Antibodies against GNbAC1 (ADA)
Time Frame
57 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Scientia Clinical Research Ltd
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
31311668
Citation
Porchet H, Vidal V, Kornmann G, Malpass S, Curtin F. A High-dose Pharmacokinetic Study of a New IgG4 Monoclonal Antibody Temelimab/GNbAC1 Antagonist of an Endogenous Retroviral Protein pHERV-W Env. Clin Ther. 2019 Sep;41(9):1737-1746. doi: 10.1016/j.clinthera.2019.05.020. Epub 2019 Jul 13.
Results Reference
derived
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Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
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