JPRN-UMIN000028302已完成未知
Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects - GT-02037 single dose study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 40years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •(1) Any subject who have present and/or past history of disease of heart and circulatory system, liver, kidney, digestive system, and blood system, central nerves system, respiratory system. (2) Hypersensitivity or Idiosyncratic to drugs (3) History of allergy to any clinically important allergy (4) A constitution prone to hypersensitivity reaction such as rash (erythema, wheal, etc) (5) Any subject have present and/or past history of drug and alcohol addiction. (6) Positive serologic findings for treponema pallidum (syphilis), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg),and/or hepatitis C virus (HCV) antibodies. (7) Positive findings of urine drug screen. (8) Any drug history within 2weeks before study day 1. (9) Use of any investigational drug within 16weeks before study day 1. (10) Donation of blood over 400mL within 14 weeks, 200mL within 4weeks before study day 1. Blood compornent donation within 2weeks. (11) Any subject not able to agree to make contraception during the study. (12) A past medical history of somatostatin analog administration (13) Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results. (14) Subjects deemed by the investigator to be inappropriate according for inclusion in the study.
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