NCT01875926已完成1 期
Phase I, Single-centre, Open-label Study to Evaluate the Pharmacokinetics of ALX-0171, Administered by Oral Inhalation or Intravenously, in Healthy Male Volunteers
Ablynx, a Sanofi company1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
研究概览
简要总结
The overall aims of the study are:
- To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i) local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations after intravenous administration.
- To further determine the safety and local and systemic tolerability of ALX-0171.
- To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Non-smoking healthy male volunteers, (18-55 years, extremes included).
- •Good health condition, as determined by medical history, physical examination and clinical laboratory testing
- •Body mass index (BMI) within normal range: 18.0 ≤ BMI < 30.0 (kg/m2)
- •Haematology and chemistry parameters within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
- •Heart rate and/or blood pressure within normal range (as judged by the Investigator)
- •Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
- •Negative urine test for selected drugs of abuse at screening
- •Negative alcohol breath test upon check-in at study unit
- •Negative hepatitis panel (including hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus antibodies (anti-HCV)), and negative human immunodeficiency virus (HIV) antibody screens
- •Willingness to consent to using an effective contraceptive method (by using 2 methods of contraception in combination with a female partner: at least 1 of the contraception methods must be a barrier contraception method, e.g., condom) during the study and for at least 3 months after last study drug administration
- •Ability to comprehend and willingness to sign an Informed Consent Form (ICF)
- •For oral inhalation only:
- •Lung function test which shows a Forced Expiratory Volume in 1 second (FEV1) ≥ 90% of predicted value
- •Ability to retro-breathe with nebulizer
- •Height between 170 and 190 cm (extremes included)
- •Ability to produce a sufficient amount of induced sputum (at least 400 μL containing visual sputum plugs) to assess immunogenicity
排除标准
- •Current smokers, or ex-smokers abstinent from tobacco for less than one year, or a history of smoking more than 10 packs a year
- •Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14 days prior to dosing
- •Signs of active pulmonary infection or other pulmonary inflammatory conditions, even in the absence of febrile episodes, in the last 14 days prior to dosing
- •History or presence of disease in the kidneys and/or heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •Malignancy, or prior malignancy, with a disease-free interval of < 5 years after diagnosis and intervention, except basal cell carcinoma (treated curatively)
- •Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis.
- •History of hypersensitivity or allergies to any drug compound, including constituents of ALX-0171
- •History of previous administration of ALX-0171, or any other inhaled biologic or drug targeting the Respiratory Syncytial Virus (RSV) F protein. In any other case of use of biologics: at least 6 months before administration of first study medication, or the time of duration of the pharmacodynamic effect, or 10 times the half-life of the respective drug, whatever is longer
- •Receipt of any investigational drug within 60 days prior to dosing
- •Intake of prescribed or over-the-counter medication within 14 days prior to dosing (≤ 3 g/day paracetamol is allowed)
- •History or presence of alcohol or drug abuse
- •Blood donation (> 500 mL) or a comparable blood loss within three months prior to dosing
- •Planned donation of germ cells, blood, organs, bone marrow during the course of the study or within 6 months thereafter
- •Any other condition or prior therapy which, in the opinion of the Investigator, would make the subject unsuitable for this study
- •Vulnerable subjects (e.g., persons kept in detention)
- •For oral inhalation only:
- •History or presence of atopy or any condition associated with airway hyperresponsiveness (e.g., allergic or non-allergic asthma, chronic obstructive pulmonary disease (COPD))
- •FEV1 drop of > 10% after inhalation of 4 mL of ALX-0171 placebo (measured at 5 min after the end of inhalation)
- •Contra-indication for sputum induction, such as (but not limited to) recent eye surgery, recent fractured ribs and recent (or history of) pneumothorax
研究组 & 干预措施
ALX-0171 Oral Inhalation - Single Dose (SD)
Experimental
干预措施: ALX-0171 (Biological)
ALX-0171 Intravenous (IV)
Experimental
干预措施: ALX-0171 (Biological)
ALX-0171 Oral Inhalation - Multiple Dose (MD)
Experimental
干预措施: ALX-0171 (Biological)
结局指标
主要结局
Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
时间窗: Day 1 to Day 4
Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples
时间窗: Day 1 to Day 9
次要结局
- Safety and tolerability: safety markers(from signing of Informed Consent Form (ICF) until last follow-up visit (i.e 35 to 42 days after first study drug administration))
- Immunogenicity: concentration of Anti-Drug Antibodies (ADA)in induced sputum (after oral inhalation only) and serum(during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration))
研究者
研究点 (1)
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