Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

September 12, 2019

Primary Completion Date

May 25, 2021

Study Completion Date

May 25, 2021

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

ONO-4685

Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.

BIOLOGICAL

Placebo

Placebo will be administered by intravenous continuous infusion at the designated speed.

BIOLOGICAL

KLH

KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.

BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (1)

Unknown

Fukuoka Clinical Site, Hakata

Sponsors
All Listed Sponsors
lead

Ono Pharmaceutical Co. Ltd

INDUSTRY