A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
研究概览
简要总结
To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body Mass Index (BMI) between 18 and 34 kg/m2
- •Normal physical and neurological examination, clinical laboratory values and ECG
- •Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subjects with ulcerative colitis)
- •Crohn's Disease Activity Index (CDAI) score of >150 and < 450 at screening (for subjects with Crohn's disease)
- •Additional inclusion criteria apply
排除标准
- •History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion
- •History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years
- •Underlying condition(s) that predisposes the subject to infections
- •Disease limited to the rectum, i.e. within 10 cm of the anal verge (for subjects with ulcerative colitis)
- •Evidence of severe disease (as evidenced by an Hb concentration less or equal to 10g/dL; toxic megacolon, or an UCDAI score greater than 10) (for subjects with ulcerative colitis)
- •Subject has short bowel syndrome (for subjects with Crohn's disease)
- •Presence of an ostomy (for subjects with Crohn's disease)
- •Presence of a fistula (for subjects with Crohn's disease)
- •Additional exclusion criteria apply
研究组 & 干预措施
Placebo arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
干预措施: Placebo for AMG 181 (Other)
Active arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
干预措施: AMG 181 (Drug)
结局指标
主要结局
To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
时间窗: 40 Weeks
次要结局
- To measure the area under the plasma concentration curve versus time of drug AMG 181.(29 Weeks)
- To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181.(29 weeks)
- To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181.(29 Weeks)