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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo |
|
| Cohort 2 | Active Comparator | GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo |
|
| Cohort 3 | Active Comparator | GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo |
|
| Cohort 4 | Active Comparator | GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNbAC1 | Drug | Monoclonal Antibody infused i.v. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events) | Serious Adverse Events (SAE), Adverse Events (AE) | 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK): GNbAC1 serum concentrations over time | GNbAC1 serum concentrations over time | 57 days |
| Immunogenicity: Antibodies against GNbAC1 (ADA) | Antibodies against GNbAC1 (ADA) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research Ltd | Sydney | New South Wales | 2031 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31311668 | Derived | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C581064 | temelimab |
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| GNbAC1 Placebo | Other | Equivalent to GNbAC1 Buffer |
|
| 57 days |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |