ACTRN12613000651785尚未招募1 期
Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RPH-203 Following a Single Dose in Healthy Male Volunteers
ucleus Network Limited0 个研究点目标入组 48 人开始时间: 2013年6月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •*Healthy male volunteers age between 18 and 45 years
- •*Body mass index between 19 and 30 kg/m2
- •*No clinically significant findings in the medical history and physical examination
- •*No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant
- •*Normal ECG, blood pressure and heart rate, unless the Investigator considers any abnormality to be Not Clinically Significant (NCS)
- •*Negative Quantiferon (Registered Trademark) test
- •*Informed consent obtained in writing for all volunteers at enrolment into the study
排除标准
- •*Family history of premature Coronary Heart Disease (CHD)
- •*Any condition requiring the regular use of any medication
- •*Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 14 days prior to screening
- •*Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to randomization
- •*Participation in another study with any investigational product within 30 days or 5 half-lives of the investigational product, whichever is greater, before Day 1 of study treatment
- •*Treatment in the previous 3 months with any drug known to have a well defined potential for toxicity to a major organ
- •*Current smoker of more than 10 cigarettes or equivalent / day prior to commencing the study, unable to completely stop smoking during the study
- •*Be in the exclusion period of any previous study with investigational drugs
- •*Symptoms of a clinically significant illness in the 3 months before the study
- •*History of significant allergic disease (e.g. medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization or any food allergy.
- •*History of autoimmune diseases, such as psoriasis, rheumatoid arthritis, inflammatory bowel disease, etc.
- •*History of any disease that is known to affect bone, excluding history of bone fracture more than 12 months before the study
- •*History of renal insufficiency or hepatic insufficiency
- •*Hypocalcaemia or relevant medical history predisposing volunteers to hypocalcaemia
- •*Blood or plasma donation of more than 500 ml during the previous 2 months before randomization and/or more than 50 ml in the 2 weeks prior to screening
- •*Current or history of malignancy disease
- •*Volunteers at risk for tuberculosis (TB), specifically volunteers with:
- •*Current clinical, radiographic or laboratory evidence of active TB
- •*History of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type
- •*Latent TB which has not been successfully treated
- •*A positive Quantiferon (Registered Trademark) test at screening or within 6 months prior to Day 1
- •*Positive test for HIV or prior positive test as confirmed by history
- •*Positive test for hepatitis B (antigens HBs, antibody HBc) or C, unless caused by immunization
- •*Current evidence of drug abuse or history of drug abuse within one year prior to screening
- •*History of alcohol abuse or active alcoholism within 1 year prior to screening i.e. consumption of more than 3 standard drinks per day
- •*Positive alcohol or urine drug screen at screening
- •*Mental condition rendering the volunteer incapable to understand the nature, scope, and possible consequences of the study
- •*Adults under guardianship and people with restriction of freedom by administrative or legal decisions
- •*Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
- •*Volunteer is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
研究者
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