6
Participants
Start Date
December 2, 2019
Primary Completion Date
May 31, 2022
Study Completion Date
May 31, 2022
NS-089/NCNP-02
"NS-089/NCNP-02 for Infusion is packaged as 50 mg/mL with 3 mL per vial. Study dosages will be infused over a 1 hour period at the following dose levels.~\[Part 1\] NS-089/NCNP-02 is administered at dose levels 1 and 3 in Cohort 1 and at dose levels 2 and 4 in Cohort 2.~Dose level 1: 1.62 mg/kg once weekly for 2 weeks; Dose level 2: 10 mg/kg once weekly for 2 weeks; Dose level 3: 40 mg/kg once weekly for 2 weeks; Dose level 4: 80 mg/kg once weekly for 2 weeks \[Part 2\] Based on the results from Part 1, two dosages are selected as study dosages in Part 2. Each selected dose are administered once a week for 24 weeks."
National Center of Neurology and Psychiatry, Kodaira
Collaborators (1)
Nippon Shinyaku Co., Ltd.
INDUSTRY
National Center of Neurology and Psychiatry, Japan
OTHER