78
Participants
Start Date
September 12, 2019
Primary Completion Date
May 25, 2021
Study Completion Date
May 25, 2021
ONO-4685
Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.
Placebo
Placebo will be administered by intravenous continuous infusion at the designated speed.
KLH
KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.
KLH, ONO-4685
Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B.
KLH, placebo
Part C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B.
Fukuoka Clinical Site, Hakata
Lead Sponsor
Ono Pharmaceutical Co. Ltd
INDUSTRY