NCT03010787已完成1 期
A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy
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
- 47
- 试验地点
- 1
- 主要终点
- Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs
研究概览
简要总结
A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parts 1 and 2
- •Adult male subjects aged 18 to 45 years inclusive.
- •Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
- •Body weight between 50.0 and 100.0 kg inclusive.
- •Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests
- •Adult male or female subjects aged 18 to 65 years.
- •Ileostomy for a minimum of 18 months for a non malignant disease indication.
- •A BMI between 18.0 and 32.0 kg/m2 inclusive.
- •Body weight between 50.0 and 100.0 kg inclusive.
- •Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests
- •Adult male or female subjects aged 18 to 65 years.
- •A confirmed diagnosis of Crohn's disease for a minimum of 6 months.
- •A BMI between 15.0 and 32.0 kg/m2 inclusive.
- •Subjects who have no other significant co-morbidity (other than those associated with Crohn's disease).
- •Subjects whose medical history, physical examination, clinical laboratory test results and 12-lead ECG have no clinically relevant abnormalities (other than those associated with Crohn's disease).
排除标准
- •Parts 1 and 2
- •A clinically significant abnormal medical history or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.
- •A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
- •A known hypersensitivity to TNF inhibitors or any of the inactive ingredients of the study treatment.
- •A history of significant gastrointestinal (GI) disease, including GI motility disorders, GI malignancy or of polyposis coli.
- •Previous surgery to the GI tract with the exception of appendectomy.
- •A history of malignancy.
- •Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
- •A history of Crohn's disease.
- •A clinically significant abnormal medical history (other than the condition leading to ileostomy) or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.
- •A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
- •A known hypersensitivity or contraindication to TNF inhibitors or any of the inactive ingredients of the study treatment.
- •A known history of heart disease.
- •Any clinical evidence of active inflammatory bowel disease.
- •Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
- •Subjects with severe Crohn's disease such as: those requiring surgery; those with a current abscess; those with a non inflammatory stricture; those with a history of obstruction.
- •Having ever received anti-TNF-α therapy or other biologics.
- •Required an increase in dose of either steroids or immunosuppressant therapy within the past 6 weeks.
研究组 & 干预措施
Part 1
Experimental
Single ascending dose of oral V565
干预措施: V565 (Drug)
Part 2 - V565
Experimental
Single dose level of oral V565 TID for 14 days
干预措施: V565 (Drug)
Part 1 and 2 - placebo
Placebo Comparator
Oral placebo single dose (Part 1) or TID for 14 days (Part 2)
干预措施: Placebo (Drug)
Part 3
Experimental
Single dose of V565 in patient volunteers
干预措施: V565 (Drug)
Part 4
Experimental
Single ascending dose of V565 in patients with Crohn's Disease
干预措施: V565 (Drug)
结局指标
主要结局
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs
时间窗: Up to 14 days
Measurement of the concentrations of V565 in ileal fluid following a single dose
时间窗: 24 hours
次要结局
- Evaluation of pharmacokinetic parameter of V565: Cmax(72 hours)
- Evaluation of pharmacokinetic parameter of V565: AUC(72 hours)
- Evaluation of pharmacokinetic parameter of V565: tmax(72 hours)
研究者
研究点 (1)
Loading locations...
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