Sept. 27, 2024 |
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Oct. 08, 2024 |
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jRCT2051240138 |
A Single/Multiple Dose Study of SSJG-009 (Phase I) |
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A Single/Multiple Dose Study of SSJG-009 (Phase I) |
Fujisawa Kouichi |
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Sunstar Inc. |
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Asia One Center 8F, 1-17 Koyochonaka, Kobe Higashinada-ku, Hyogo, Japan |
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+81-80-9937-4055 |
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ssjg009@jp.sunstar.com |
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Fujisawa Kouichi |
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Sunstar Inc. |
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Asia One Center 8F, 1-17 Koyochonaka, Kobe Higashinada-ku, Hyogo, Japan |
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+81-80-9937-4055 |
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ssjg009@jp.sunstar.com |
Not Recruiting |
Oct. 01, 2024 |
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Oct. 01, 2024 | ||
9 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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placebo control |
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parallel assignment |
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other |
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1. Healthy Japanese adult males aged 20 to 40 years on the day of consent, who the investigator or subinvestigator considers to be in good physical health and be clinically normal based on a full-body examination, including medical history, blood pressure, and pulse rate. |
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(1) Subjects with a health condition that may affect the absorption, distribution, metabolism, and excretion of the investigational drug, or a history of such a condition (e.g., history of resection of the liver, kidneys, gallbladder, or digestive tract). |
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20age old over | ||
40age old not | ||
Male |
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Healthy Japanese adult males |
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Treatment group:SSJG-009 Placebo group:Placebo |
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Safety, Pharmacokinetics |
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Sunstar Inc. |
Medical Corporation Heishinkai OPHAC Hospital IRB | |
4-1-29 Miyahara, Yodogawa-ku, Osaka-city, Osaka, Osaka | |
+81-6-6395-9000 |
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ophach_irb@heishinkai.com | |
Approval | |
Sept. 20, 2024 |
No |
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none |