Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
- Registration Number
- NCT03179423
- Lead Sponsor
- GeNeuro Australia PTY Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Subjects diagnosed with type 1 diabetes in the 4 years prior to signed informed consent;
- Peak stimulated C-peptide of ≥0.2 nmol/L during a mixed meal tolerance test performed during the Screening period;
- 18 to 55 years of age (both inclusive);
- Body weight >40 to ≤100 kg;
- Subjects positive for at least one diabetes-associated autoantibody (insulin, glutaminic-acid-decarboxylase-65 [GAD-65], tyrosine phosphatase-related antigen 2 [IA-2], ZnT8 or islet-cell antibody [ICA]).
Main
- Subjects with type 2 diabetes;
- Pregnant and nursing women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Monthly IV repeated dose GNbAC1 GNbAC1 Monthly IV repeated dose
- Primary Outcome Measures
Name Time Method Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE) Week 1 to 24/48 Serious Adverse Events (SAE) and Adverse Events (AE)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Macquarie University Hospital
🇦🇺Macquarie University, New South Wales, Australia
Eastern Health
🇦🇺Box Hill, Victoria, Australia
Keogh Institute of Medical Research
🇦🇺Nedlands, Western Australia, Australia
AIM Centre
🇦🇺Merewether, New South Wales, Australia
Mater Misericordiae Ltd and Mater Medical Research Institute Limited
🇦🇺South Brisbane, Queensland, Australia
Ipswich Research Centre
🇦🇺Ipswich, Queensland, Australia
Gold Coast Hospital and Health Service
🇦🇺Southport, Queensland, Australia
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
🇦🇺Elizabeth Vale, South Australia, Australia
Southern Adelaide Local Health Network - Repatriation General Hospital
🇦🇺Adelaide, South Australia, Australia
St Vincent's Hospital (Melbourne) Limited
🇦🇺Fitzroy, Victoria, Australia
Barwon Health - University of Geelong
🇦🇺Geelong, Victoria, Australia
Heidelberg Repatriation Hospital
🇦🇺Heidelberg, Victoria, Australia
Northern Sydney Local Health District - Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia