NCT01992367已完成1 期
A Phase 1, Randomised, Double Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of ASLAN003 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Safety
研究概览
简要总结
This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of ASLAN003 in healthy subjects
详细描述
This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.
The study is divided into two parts:
- Part A: SAD cohorts and 1 cohort to assess food effect of ASLAN003 PK.
- Part B: MAD cohorts with one cohort being of healthy elderly subjects.
There will be a sentinel pair of subjects for each of SAD Cohorts 1, 2 and 3 who will be dosed first and then the same dose will be given to the rest of the subjects in the respective cohorts.
In addition, 8 subjects will receive ASLAN003 under both fed and fasted conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for all subjects are as follows:
- •are capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);
- •are able to communicate well with the Investigator, and understand and comply with the requirements of the study;
- •male subjects aged between 21 and 50 years, inclusive (Part A and Cohorts 5, 6 and 7 of Part B only); male subjects and female subjects of non childbearing potential aged ≥55 years (Cohort 8 of Part B only);
- •body mass index (BMI) in the range of 18 to 30 kg/m2, inclusive;
- •healthy, as determined by pre study medical history, physical examinations, vital sign measurements, electrocardiogram (ECG; 12 lead reporting RR, PR, QRS, corrected QT [QTc] and QT interval corrected for heart rate using Fridericia's formulas [QTcF]) recordings with no evidence of clinically relevant medical disorders based on the opinion of the Investigator;
- •whose out-of-normal range clinical laboratory test results are not clinically relevant and are acceptable to the Investigator;
- •male subjects must be willing to use barrier contraception during sexual intercourse, i.e. condoms, even if their partners are post-menopausal, surgically sterile or are using accepted contraceptive methods, from the first day of dose administrations until 3 months after the last dose administration;
排除标准
- •The exclusion criteria for all subjects are as follows:
- •have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study;
- •history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP;
- •history or evidence of a clinically significant disorder, condition or disease (including, but not limited to, cardiopulmonary, oncologic, autoimmune, immunogenic, renal, metabolic, haematological or psychiatric), that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- •existence of any surgical or medical condition which, in the judgement of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the IP;
- •clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to randomisation (e.g. common cold, viral syndrome, flu-like symptoms, etc.);
- •active or recent history (within 30 days prior to randomisation) of acute viral infection of the skin (e.g. Herpes simplex, Molluscum contagiosum);
- •active or history of psoriasis, or a first-degree relative with active or history of psoriasis;
- •known history or evidence of active or latent tuberculosis infection (e.g. positive tuberculin skin test showing induration >5 mm or positive tuberculin blood test) in absence of previous Bacillus Calmette Guerin vaccination, or recent exposure (within 6 months prior to randomisation in this study) to an individual with active tuberculosis or with intention to travel to a country with a high risk of tuberculosis during the study period (including the follow up period);
- •history of autoimmune disease including but not limited to lupus, rheumatoid arthritis, autoimmune thyroid disease and immune thrombocytopenia;
- •with QT or QTcF values higher than 450 ms at screening;
- •history of regular alcohol consumption (within 6 months prior to randomisation in this study), defined as: an average weekly intake of greater than 21 units or any average daily intake of greater than 3 units. One unit is equivalent to a half pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine;
研究组 & 干预措施
Placebo
Placebo Comparator
placebo arm
干预措施: ASLAN003 ACTIVE (Drug)
ASLAN003
Other
Active drug
干预措施: ASLAN003 ACTIVE (Drug)
结局指标
主要结局
Safety
时间窗: 6 months
Safety assessments will include 12 lead ECGs, physical examiniation, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events
次要结局
未报告次要终点
研究者
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