jRCT2080225249已完成1 期
A phase I trial to evaluate the safety, tolerability and pharmacokinetics of RBM-007 administered subcutaneously in healthy volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- RIBOMIC Inc.
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- treatment-emergent adverse events
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
- This is a open label, unblinded, non-comparative Phase I study.
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Is willing and able to provide written and signed informed consent by himself, after receiving explanation of the purpose and contents of this study in writing
- •Is healthy male Japanese aged 20 to 45 years old, both inclusive
- •Has a body weight of 50 kg or above
- •Has body mass index (BMI) between 18.5 to 25.0 kg/m2, exclusive of 25.0
- •Is in generally good health based on medical history, physical examination, clinical laboratory tests and so on
- •Has azoospermia, vasectomized or consented to use appropriate contraception methods (combination of 2 methods, such as use of condoms and spermicides) during the period pre-specified in this trial
- •Is capable of understanding the trial, and complying with the requirements for the protocol, judged by the Investigator
排除标准
- •Has poorly controlled and clinically significant disorder in neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, endocrine, hematological, immunological, dermatological or psychiatric system, or has a medical history of aforementioned them, which gives possibly impact to the study results
- •Has a history of recurrent or severe allergies to food, medicine, latex, etc, or a history of either anaphylactic reactions or serious intolerance against prescribed medicine, over-the-counter medicine or food
- •Has clinically significant abnormalities in vital signs, clinical laboratory tests or 12-lead ECG at screening test or a period prior to IP administration
- •Has disorder of clinical laboratory tests for hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] or renal function [urea nitrogen (BUN), serum creatinine], exceeding upper limit of normal range at screening test or prior to IP administration
- •Has a positive test result for hepatitis, HIV or syphilis at screening test
- •Has history of treatment with growth hormone
- •Has had acute disease associated with dehydration (e.g., nausea, vomiting, diarrhea) within 90 days prior to IP administration
- •Has used prescribed medicine, over-the-counter medicine or dietary supplement, which could affect safety or PK of IP within 10 days prior to IP administration
- •Has used any other investigational product or investigational medical device within 90 days prior to IP administration
- •Consumes 14 units or more of alcohol per week (one unit corresponds to 360 mL of beer, 100 mL of wine or 35 mL of spirits), or has history of alcoholism or drug/chemical abuse
- •Consumes 6 or more cups of caffeinated beverages (approx. 720 mg of caffeine) per day, such as coffee, tea, cola, energy drink or any other
- •Has had 400 mL or more of blood drawing (including blood donation) within 90 days prior to IP administration, or had 200 mL or more of blood drawing (including blood donation) within 30 days prior to IP administration, or donated blood component (plasma or platelet) within 14 days prior to IP administration
- •Has a positive urine test for drug abuse at screening test or prior to IP administration
- •Consumes smokes more than 10 cigarettes per day, or uses equivalent or more amount of the following nicotine-containing products: snuff tobacco, chewing tobacco, cigars, pipes, nicotine pads and nicotine substitutes
- •Has any condition that in the view of the Investigator, places the subject at high risk place of not completing the study
- •Is employed by the study site, or is a family member of such employee, or has a dependency relationship with such employee (e.g., spouse, parent, child, sibling), or may consent under duress
- •Is considered by the Investigator as an inadequate subject for this study due to any other reasons than above
结局指标
主要结局
treatment-emergent adverse events
Safety and tolerability
Cmax
Pharmacokinetics
Cmin
Pharmacokinetics
tmax
Pharmacokinetics
t1/2
Pharmacokinetics
AUC0-t
Pharmacokinetics
AUC0-inf
Pharmacokinetics
Vd/F
Pharmacokinetics
CL/F
Pharmacokinetics
MRT
Pharmacokinetics
次要结局
未报告次要终点
研究者
研究点 (1)
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