Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
- Conditions
- Healthy Volunteers
- Interventions
- Biological: ONO-4685Biological: PlaceboBiological: KLHBiological: KLH, ONO-4685Biological: KLH, placebo
- Registration Number
- NCT04079062
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-4685 (PartA, D) ONO-4685 - Placebo (PartA, D) Placebo - KLH+placebo (Part B) KLH - KLH+ONO-4685 (PartC) KLH, ONO-4685 - KLH+placebo (PartC) KLH, placebo -
- Primary Outcome Measures
Name Time Method Body weight [Safety and Tolerability] Up to 84 days Summary statistics of body weight
Vital sign [Safety and Tolerability] Up to 84 days Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2
ECG parameter test [Safety and Tolerability] Up to 84 days Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF)
Adverse events [Safety and Tolerability] Up to 84 days Number of participants with adverse events as assessed by CTCAE v5.0
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)
Body temperature [Safety and Tolerability] Up to 84 days Summary statistics of body temperature
- Secondary Outcome Measures
Name Time Method Vss [Pharmacokinetic] (PartA, C, and D) Up to 84 days Assessment of the Vss of ONO-4685
Cmax [Pharmacokinetic] (PartA, C, and D) Up to 84 days Assessment of the Cmax 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
Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D) Up to 84 days Serum cytokine concentration
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
CL [Pharmacokinetic] (PartA, C, and D) Up to 84 days Assessment of the CL of ONO-4685
Hemocyte test [Pharmacodynamics] (PartA, C, and D) Up to 84 days Hemocyte test
Trial Locations
- Locations (1)
Fukuoka Clinical Site
🇯🇵Hakata, Fukuoka, Japan