The monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous Multiple Sclerosis associated RetroVirus (MSRV), which could play a critical role in different autoimmune disorders, notably type 1 diabetes (T1D). This study is a multicentre study evaluating for the first time the safety and efficacy of GNbAC1 in T1D subjects for a first bouble-blind period of 20 weeks followed by an optional open-label period of 24 weeks. The primary objective of the study is to assess the safety and tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D. Secondary objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of T1D.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Monthly IV repeated dose
Monthly IV repeated dose
Macquarie University Hospital
Macquarie University, New South Wales, Australia
AIM Centre
Merewether, New South Wales, Australia
Northern Sydney Local Health District - Royal North Shore Hospital
St Leonards, New South Wales, Australia
Ipswich Research Centre
Ipswich, Queensland, Australia
Mater Misericordiae Ltd and Mater Medical Research Institute Limited
South Brisbane, Queensland, Australia
Gold Coast Hospital and Health Service
Southport, Queensland, Australia
Southern Adelaide Local Health Network - Repatriation General Hospital
Adelaide, South Australia, Australia
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Eastern Health
Box Hill, Victoria, Australia
St Vincent's Hospital (Melbourne) Limited
Fitzroy, Victoria, Australia
...and 3 more locations
Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE)
Serious Adverse Events (SAE) and Adverse Events (AE)
Time frame: Week 1 to 24/48
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