NCT03900325Unknown2 期
A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 6
- 试验地点
- 5
- 主要终点
- Frequency of clinically significant laboratory abnormalities
研究概览
简要总结
This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 1 or type 2 diabetes
- •Diagnosed with diabetic gastroparesis, defined by:
- •3 month past or current history of symptoms of gastroparesis (e.g. nausea, vomiting, bloating, abdominal pain, or feeling full earlier than normal after eating)
- •Screening or historical scintigraphy (3 years prior to screening) with > 20% of solid contents retained at 4 hours.
- •BMI >= 20.0 and < = 50.0 kg/m2
排除标准
- •Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
- •Participants with any active prokinetic device are excluded, unless device is turned off for at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
- •Participants who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •Participants with uncontrolled diabetes. Participants with controlled diabetes are allowed (insulin is allowed). HbA1c>9.9% at screening are excluded.
研究组 & 干预措施
Nimacimab
Experimental
2.5 mg/kg
干预措施: Nimacimab (Drug)
Placebo
Placebo Comparator
0.9% sodium chloride
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of clinically significant laboratory abnormalities
时间窗: Day 38
Frequency of clinically significant vital signs
时间窗: Day 38
Frequency of clinically significant ECGs
时间窗: Day 38
次要结局
- Nimacimab serum concentration(Day 3, Day 8, Day 10, Day 38)
研究者
研究点 (5)
Loading locations...
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