JRCT ID: jRCT2071220100
Registered date:31/01/2023
ONO-1110-01:Phase 1 study of the safety, tolerability, pharmacokinetics of ONO-1110 in healthy Japanese adult male subjects
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Healthy volunteers(The planned indication has not been determined.) |
Date of first enrollment | 17/02/2023 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 1) Part A:Single dose Part Subjects receive single oral dose of ONO-1110 or placebo. 2) Part B:Multiple dose Part Subjects receive multiple oral doses of ONO-1110 or placebo. 3) Part C:Cerebrospinal Fluid Collection Part Subjects receive single oral dose of ONO-1110. |
Outcome(s)
Primary Outcome | Safety (All Part), Pharmacokinetic (All Part), Compound concentration in cerebrospinal fluid (Part C only) |
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Secondary Outcome |
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 | Hirashima Yoshinori |
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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 | Yoshinori Hirashima |
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 |