Exploratory Phase Trial of OCH-NCNP1 in Healthy Subjects and Patients with Multiple Sclerosis - Exploratory Phase Trial of OCH-NCNP1

ational Center of Neurology and Psychiatry0 个研究点目标入组 30 人开始时间: 2012年11月23日最近更新: 2023年10月17日

适应症

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•Exclusion criteria for healthy subjects 1. Women who are pregnant or lactating 2. History of liver diseases 3. Positive for Beta-glucan or positive for QuantiFERON 4. History of HIV infection 5. History of HBV or HCV infection 6. Subjects who were administered with some medicine within two weeks 7. Compromised subjects 8. Inflammatory bowel disease 9. Subjects with prolongation of QT/QTc interval. 10. Smokers Exclusion criteria for patients with relapsing remitting multiple sclerosis 1. Patients who diagnosed as Neuromyelitis Optica 2. Women who are pregnant or lactating 3. Patients who are allergic to Gd-contrast medium 4. History of liver diseases or liver transplantation 5. Liver dysfunction in the screening test and baseline physical examination 6. Beta-glucan-positive or QuantiFERON-positive 7. Positive for Anti-Aquaporin 4 antibody 8. History of HIV infection 9. History of HBV or HCV infection 10. Lymphocyte number < 800 /mm3 in peripheral blood 11. Compromised Patients 12. Inflammatory Bowel disease 13. Subjects with prolongation of QT/QTc interval. 14. Smokers 15. Bronchial Asthma Other protocol-defined exclusion criteria may apply.

发起方

ational Center of Neurology and Psychiatry