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

Phase 1

• Conditions: Multiple Sclerosis

• Registration Number: JPRN-UMIN000009382
• Lead Sponsor: ational Center of Neurology and Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-23
• Study Completion: 2017-08-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse effects

Secondary Outcome Measures

Name	Time	Method
(1) Exploration of biomarkers related to the efficacy 1) DNA microarray analysis 2) Frequency of NKT, NK and T cell subsets 3) Frequency of Th1/Th2/Th17 cells 4) Frequency of NK1/NK2 cells 5) Cytokine concentrations of the serum and cerebrospinal fluid (2) Pharmacokinetics (3) Expanded Disability Status Scale (EDSS) and Functional Scale (FS) (4) MRI scan 1) Number of new T2-hyperintense lesions 2) Number of new T1-hypointense lesions 3) Number of Gd-enhancing lesions in T1-weighted images 4) FLAIR images