NCT01374503终止1 期
A Phase I, Single-centre, Randomised, Single-blinded, Placebo-controlled Single Ascending Dose Study, Followed by an Open-label Extension, Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of ALX-0651, Administered Intravenously to Healthy Male Volunteers
Ablynx, a Sanofi company1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events
研究概览
简要总结
The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, aged >= 18 and <= 55 at screening.
- •Willing to consent to using an effective contraceptive method for at least 3 months after test substance administration.
- •Non-smokers, or ex-smokers abstinent from tobacco for at least 1 year.
- •Body mass index (BMI): 19 - 29 kg/m2 (extremes included).
- •Haematology and chemistry parameters within normal range or showing no clinically relevant deviations, as judged by the Medical Investigator. For haematology, haemoglobin and white blood cell (WBC) count must be within normal limits. For chemistry, calcium, alkaline phosphatase (ALP), (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) must be within normal limits.
- •Normal electrocardiogram, showing no clinically relevant deviations, as judged by the Investigator. QTc <= 450 ms.
- •No history or presence of diseases of the kidneys, heart, lungs, liver, gastrointestinal tract or endocrine organs, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •No history of clinically relevant allergies.
- •Obtained, signed and dated informed consent.
- •Ability and willingness to comply with protocol requirements.
排除标准
- •Intake of any prescribed systemic or topical medication within 14 days prior to dosing.
- •Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
- •History of thrombosis.
- •Chronic infection or acute significant infection or fever within the last 5 weeks prior to the start of test substance administration.
- •Subjects with any abnormality of the spleen (confirmed by echography) or history of splenic disease, or subjects that underwent splenectomy in the past.
- •Blood donation (>500 ml) or a comparable blood loss within three months prior to the start of drug administration.
- •Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason, with special emphasis on eligibility for the aphaeresis procedure.
- •Participation in an investigational drug study within 60 days prior to drug administration, or within less than 6 times the terminal elimination half-life of the test substance used in the respective trial (whichever is longer).
- •Malignancy, or prior malignancy, with a disease-free interval of < 5 years after diagnosis and intervention, except curative treatment for non-melanoma skin cancer or resected carcinoma in situ.
结局指标
主要结局
Number of treatment emergent adverse events
时间窗: until 1 month after study drug administration
次要结局
- CD34 positive cell count in blood(from predose until 14 days after study drug administration)
- maximum plasma concentration (Cmax) of ALX-0651(from predose until 48 hours after study drug administration)
研究者
研究点 (1)
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