Viela Bio has initiated a Phase I clinical trial to evaluate the safety and tolerability of VIB9600 for the treatment of adult patients with immune mediated diseases.
The single-centre, randomised, blinded, placebo-controlled, interventional trial will be conducted in collaboration with CTI Clinical Trial & Consulting.
The first-in-human trial is expected to enrol a maximum of 64 healthy adult subjects enrolled in up to eight groups in the US.
During the trial, the enrolled subjects will receive single and multiple-ascending doses of VIB9600 by intravenous infusion or subcutaneous injection, or placebo.
The primary objective of the trial is safety and tolerability of single and multiple doses of VIB9600 over a period of 113 days.
The trial’s secondary objectives include pharmacokinetics (PK) of VIB9600 following single and multiple-dose administration, and immunogenicity of VIB9600 following single and multiple-dose administration as measured by the presence of anti-drug antibodies (ADA) to VIB9600.
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The trial, scheduled to be completed by May next year, has started enrolling patients and plans to dose the first patient in the first week of next month.
Viela Bio CEO Bing Yao said: “After only six months as a company, our people continue to make great strides to advance our pipeline.”
Based in Gaithersburg, Maryland, US, Viela Bio is a clinical-stage biotechnology company involved in developing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause.