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To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and Caucasian healthy adult male subjects. In addition, in Japanese healthy adult male subjects, to investigate dosing condition of Keyhole limpet hemocyanin (KLH) and to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion after treating with KLH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4685 (PartA, D) | Experimental |
| |
| Placebo (PartA, D) | Placebo Comparator |
| |
| KLH+placebo (Part B) | Experimental |
| |
| KLH+ONO-4685 (PartC) | Experimental |
| |
| KLH+placebo (PartC) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4685 | Biological | Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events [Safety and Tolerability] | Number of participants with adverse events as assessed by CTCAE v5.0 | Up to 84 days |
| Vital sign [Safety and Tolerability] | Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2 | Up to 84 days |
| Body temperature [Safety and Tolerability] | Summary statistics of body temperature | Up to 84 days |
| Body weight [Safety and Tolerability] | Summary statistics of body weight | Up to 84 days |
| ECG parameter test [Safety and Tolerability] | Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF) | Up to 84 days |
| Laboratory test [Safety and Tolerability] | Summary statistics of laboratory test (hematologic test, blood biochemistry test, blood coagulation test, immunoserologic test urinalysis) | Up to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax [Pharmacokinetic] (PartA, C, and D) | Assessment of the Cmax of ONO-4685 | Up to 84 days |
| Tmax [Pharmacokinetic] (PartA, C, and D) | Assessment of the Tmax of ONO-4685 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junichiro Manako | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka Clinical Site | Hakata | Fukuoka | Japan |
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| Placebo | Biological | Placebo will be administered by intravenous continuous infusion at the designated speed. |
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| KLH | Biological | KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration. |
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| KLH, ONO-4685 | Biological | 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 | Biological | 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. |
|
| Up to 84 days |
| AUC [Pharmacokinetic] (PartA, C, and D) | Assessment of the AUC168h, AUClast, and AUCinf of ONO-4685 | Up to 84 days |
| T1/2 [Pharmacokinetic] (PartA, C, and D) | Assessment of the T1/2 of ONO-4685 | Up to 84 days |
| CL [Pharmacokinetic] (PartA, C, and D) | Assessment of the CL of ONO-4685 | Up to 84 days |
| Vss [Pharmacokinetic] (PartA, C, and D) | Assessment of the Vss of ONO-4685 | Up to 84 days |
| Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D) | Serum cytokine concentration | Up to 84 days |
| Hemocyte test [Pharmacodynamics] (PartA, C, and D) | Hemocyte test | Up to 84 days |
| Pharmacodynamics (Part B and C) | Anti-KLH antibody | Up to 84 days |
| Immunogenicity (PartA, C, and D) | Anti-ONO-4685 antibody | Up to 84 days |
| ID | Term |
|---|---|
| C032808 | keyhole-limpet hemocyanin |
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