JRCT ID: jRCT2071220081
Registered date:23/12/2022
ONO-4685-04: ONO-4685 Phase 1 study
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Auto immune disease |
Date of first enrollment | 17/01/2023 |
Target sample size | 72 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | ONO-4685:Single-dose intravenous continuous infusion and subcutaneous administration |
Outcome(s)
Primary Outcome | Safety, Pharmacokinetics |
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Secondary Outcome | Pharmacodynamics,Immunogenicity |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 45age old |
Gender | Male |
Include criteria | 1) Japanese healthy adult male subjects 2) Age at the time of informed consent: 18 to 45 3) BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2 |
Exclude criteria | 1) 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. 2) Subjects with current or with a history of severe allergy to drugs or foods 3) Subjects with current or with a history of drug or alcohol abuse |
Related Information
Primary Sponsor | Namba Yoshinobu |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Center Information Medical |
Address | 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka Osaka Japan 618-8585 |
Telephone | +81-120-626-190 |
clinical_trial@ono-pharma.com | |
Affiliation | Ono Pharmaceutical Co.,LTD |
Scientific contact | |
Name | Yoshinobu Namba |
Address | 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka Osaka Japan 618-8585 |
Telephone | +81-120-626-190 |
clinical_trial@ono-pharma.com | |
Affiliation | Ono Pharmaceutical Co.,LTD |