jRCT2080225152已完成1 期
Dose escalation study of single and multiple subcutaneous injections of GT-02037 in healthy Japanese adult males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Single-center, Randomized, Double-blind, Placebo-controlled Single And Multiple Subcutaneous Injection Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 40age old under（—）
- 性别
- Male
入选标准
- •(1) Healthy Japanese adult male
- •(2) 20 to 40 years old at the time of consent
- •(3) Body weight: over 50 kg
- •(4) Body Mass Index: between 18.5 and 25.0 at the screening examination
- •(5) Provided written informed consent
排除标准
- •(1) Those who have prior medical history of central nervous system, circulatory system, respiratory system, blood / hematopoietic system, gastrointestinal system, hepatic / renal function, etc. conditions that are considered inappropriate for this study
- •(2) Hypersensitivity or idiosyncratic reaction to any drug
- •(3) Those having a food allergy or allergic disease considered inappropriate for this study
- •(4) Those who are susceptible to hypersensitivity rash symptoms (erythema, wheal, etc.)
- •(5) Alcohol or drug dependence
- •(6) Those having immunological test result abnormalities (HBs antigen, HCV antibody, syphilis test (RPR method, TP antibody), HIV antigen / antibody)
- •(7) Those who have a positive result in the urine drug screening test
- •(8) Those who have consumed foods / supplements containing alcohol, grapefruit (fruit / pulp), or St. John's wort within one week prior to investigational drug administration
- •(9) Those who have experienced muscle pain due to intense exercise or sunburn within one week prior to investigational drug administration
- •(10) Those administrated of any investigational drug within two weeks before this study
- •(11) Those who have participated in other clinical trials or studies and received the drug within 16 weeks before this study (in the case of other clinical bioequivalence studies, within 12 weeks)
- •(12) Those who have given 400mL or more of whole blood within 12 weeks, 200mL or more within 4 weeks, or blood components within 2 weeks before this study
- •(13) Those who cannot practice contraception from the administration of the investigational drug to post-test (or follow-up)
- •(14) Those previously administrated GT-02037 or somatostatin analog drug
- •(15) Those with clinically significant abnormalities in laboratory tests, vital signs, 12-lead ECG tests, or medical examinations at the time of subject screening
- •(16)Those who are judged by the clinical investigator or sub-investigators to be inappropriate for participation in this study
研究者
研究点 (1)
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