Trials / Completed
CompletedNCT04079062
Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-09-12
- Primary completion
- 2021-05-25
- Completion
- 2021-05-25
- First posted
- 2019-09-06
- Last updated
- 2024-05-03
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04079062. Inclusion in this directory is not an endorsement.