Diabetes Mellitus, Type 1 Clinical Trial
Official title:
A Single Blind, Randomised, Placebo Controlled, Repeat Dose, Dose Escalating Study Investigating Safety, Tolerability Pharmacokinetics, Pharmacodynamics and the Beta-Cell Preserving Effect of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of
intravenously administered otelixizumab. In addition, the C-peptide decline in new onset type
1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be
investigated with a view to identifying trends and early immunological biomarkers which could
predict response in halting/slowing Beta-cell destruction in this patient population.
This exploratory study will explore the safety and tolerability between the well tolerated
but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which
efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr
Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the tolerability
dose response is considered a necessary first step to determining the therapeutic index of
otelixizumab.
n/a
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