SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101 (AURIGA1)
2020年10月26日 更新者：Applied Molecular Transport
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
52
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
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)
Exclusion Criteria:
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).
PART B
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Single or daily dosing at doses A, B, C, D, E, F
其他名称：
|
|
实验性的：AMT-101
|
Single or daily dosing at doses A, B, C, D, E, F
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Treatment-emergent adverse events (safety and tolerability)
大体时间：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.
|
14 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum plasma concentration (CMax)
大体时间：14 days
|
To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.
|
14 days
|
|
Pharmacodynamics
大体时间：14 days
|
To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.
|
14 days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of anti-drug antibodies against AMT-101
大体时间：14 days
|
Incidence of anti-drug antibodies against AMT-101 in healthy adult volunteers and subjects with UC.
|
14 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Bittoo Kanwar, MD、Applied Molecular Transport
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年4月1日
初级完成 (实际的)
2020年4月30日
研究完成 (实际的)
2020年4月30日
研究注册日期
首次提交
2019年5月23日
首先提交符合 QC 标准的
2020年1月8日
首次发布 (实际的)
2020年1月13日
研究记录更新
最后更新发布 (实际的)
2020年10月28日
上次提交的符合 QC 标准的更新
2020年10月26日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.