A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
详细描述
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance.
Patients may be
- naïve to anti-TNFα therapy or
- have failed or demonstrated intolerance to anti-TNF-α therapy.
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
- Double (Participant, Investigator)
盲法说明
matching placebo
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PART A (Healthy Volunteers)
- •Male subject in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening
- •Between 18 and 45 years of age, inclusive.
- •Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).
- •PART B (Adult Ulcerative Colitis)
- •Male and Female patients 18 years and older
- •Documented diagnosis of UC for at least 3 months duration
- •Stable mild to moderate UC, as defined by the following criteria: Total Mayo score (excluding PGA) at least 3 but not greater than 7:
- •Patients must have failed or demonstrated intolerance to aminosalicylates (e.g., 5-aminosalicylic acid, mesalamine)
排除标准
- •PART A and PART B
- •Known hypersensitivity or allergy to AMT-101 or excipient contained in the drug formulation.
- •Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
- •Clinical findings of Crohn's disease
- •A prior history of surgery for UC
- •Prior use of integrin antagonists (vedolizumab, natalizumab), JAK kinase inhibitors (tofacitinib), cyclosporin or tacrolimus
研究组 & 干预措施
AMT-101
AMT-101
干预措施: AMT-101 (Drug)
Placebo
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Incidence of Treatment-emergent adverse events (safety and tolerability)
时间窗: 14 days
Single and multiple ascending doses of AMT-101 in healthy adult volunteers and patients with active UC by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v4.03 and Modified Mayo Score criteria.
次要结局
- Maximum plasma concentration (CMax)(14 days)
- Pharmacodynamics(14 days)