GAITHERSBURG, MD, USA I August 20, 2018 I Viela Bio announced today the start of the company’s first clinical trial, a phase 1, first-in-human clinical trial of VIB9600, which is being developed for the treatment of adult patients with immune mediated diseases. Following the completion of the required pre-clinical studies, Viela Bio filed the IND and the FDA approved the phase I trial that will be executed in collaboration with CTI Clinical Trial & Consulting as the CRO.
“After only six months as a company, our people continue to make great strides to advance our pipeline,” commented Bing Yao, CEO of Viela Bio.
Trial recruitment is underway and the first subjects have signed informed consent. Viela Bio expects the first dose to be administered in the first week of September.
About the Phase 1, First-In-Human Study of VIB9600
VIB9600 or placebo will be administered to a maximum of 64 healthy adult volunteers enrolled in up to eight groups to evaluate the safety and tolerability of single and multiple doses of VIB9600. Analyses of the differences between the groups will inform decisions for future studies. Further details of the study (NCT 03621605) are posted on clinicaltrials.gov.
About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.
SOURCE: Viela Bio
Post Views: 25
GAITHERSBURG, MD, USA I August 20, 2018 I Viela Bio announced today the start of the company’s first clinical trial, a phase 1, first-in-human clinical trial of VIB9600, which is being developed for the treatment of adult patients with immune mediated diseases. Following the completion of the required pre-clinical studies, Viela Bio filed the IND and the FDA approved the phase I trial that will be executed in collaboration with CTI Clinical Trial & Consulting as the CRO.
“After only six months as a company, our people continue to make great strides to advance our pipeline,” commented Bing Yao, CEO of Viela Bio.
Trial recruitment is underway and the first subjects have signed informed consent. Viela Bio expects the first dose to be administered in the first week of September.
About the Phase 1, First-In-Human Study of VIB9600
VIB9600 or placebo will be administered to a maximum of 64 healthy adult volunteers enrolled in up to eight groups to evaluate the safety and tolerability of single and multiple doses of VIB9600. Analyses of the differences between the groups will inform decisions for future studies. Further details of the study (NCT 03621605) are posted on clinicaltrials.gov.
About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.
SOURCE: Viela Bio
Post Views: 25
