Healthy Volunteers
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALKLH, 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.
BIOLOGICALONO-4685
Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.
BIOLOGICALPlacebo
Placebo will be administered by intravenous continuous infusion at the designated speed.
BIOLOGICALKLH
KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.
BIOLOGICALKLH, 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.
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese healthy adult male subjects (PartA, B, and C) * Caucasian healthy adult male subjects (Part D) * Age (at the time of informed consent): ≥20 yeas, ≤ 45 yeas * Body weight (at the time of screening test): ≥50 kg
Exclusion criteria
* Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease. * Subjects with current or with a history of severe allergy to drugs or foods * Subjects with current or with a history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events [Safety and Tolerability] | Up to 84 days | Number of participants with adverse events as assessed by CTCAE v5.0 |
| Vital sign [Safety and Tolerability] | Up to 84 days | Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2 |
| Body temperature [Safety and Tolerability] | Up to 84 days | Summary statistics of body temperature |
| Body weight [Safety and Tolerability] | Up to 84 days | Summary statistics of body weight |
| ECG parameter test [Safety and Tolerability] | Up to 84 days | Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF) |
| Laboratory test [Safety and Tolerability] | Up to 84 days | Summary statistics of laboratory test (hematologic test, blood biochemistry test, blood coagulation test, immunoserologic test urinalysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D) | Up to 84 days | Serum cytokine concentration |
| Hemocyte test [Pharmacodynamics] (PartA, C, and D) | Up to 84 days | Hemocyte test |
| Cmax [Pharmacokinetic] (PartA, C, and D) | Up to 84 days | Assessment of the Cmax of ONO-4685 |
| Immunogenicity (PartA, C, and D) | Up to 84 days | Anti-ONO-4685 antibody |
| Pharmacodynamics (Part B and C) | Up to 84 days | Anti-KLH antibody |
| Tmax [Pharmacokinetic] (PartA, C, and D) | Up to 84 days | Assessment of the Tmax of ONO-4685 |
| AUC [Pharmacokinetic] (PartA, C, and D) | Up to 84 days | Assessment of the AUC168h, AUClast, and AUCinf of ONO-4685 |
| T1/2 [Pharmacokinetic] (PartA, C, and D) | Up to 84 days | Assessment of the T1/2 of ONO-4685 |
| CL [Pharmacokinetic] (PartA, C, and D) | Up to 84 days | Assessment of the CL of ONO-4685 |
| Vss [Pharmacokinetic] (PartA, C, and D) | Up to 84 days | Assessment of the Vss of ONO-4685 |
Countries
Japan
Outcome results
None listed