NCT01427699已完成2 期
A Phase II Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by blocking inflammation in the pancreas.
详细描述
This is a phase I, open label study of the safety and pharmacokinetics of T2-18C3 in patients with T2D. Nine patients will receive four biweekly IV infusions of the study drug, T2-18C3, at a dose level of 1.25 mg/kg. These patients will be followed for a total of 90 days to examine safety, pharmacokinetics, and preliminary efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •American Diabetes Association (ADA) diagnostic criteria for Type 2 Diabetes (T2D)
- •HbA1c >7.0% and ≤ 10%
- •Current T2D duration > 3 months at Screening
- •T2D and other diseases must be stable. Stable disease is defined as disease which did not require a change in medication or dosing level on 4 or more consecutive days or 7 days in total within 28 days prior to Day
- •Age ≥ 18 and ≤ 70 at Screening
- •BMI ≥ 23 and ≤ 40 kg/m2
- •For female patients of child-bearing age, a negative serum pregnancy test. For patients with reproductive potential, a willingness to utilize adequate contraception (oral contraception plus a mechanical barrier) and not become pregnant (or have their partner[s] become pregnant) during the study
- •Agrees not to change diet and exercise regimen during the trial
- •Signed and dated Ethics Committee (EC) approved informed consent before any protocol-specific screening procedures are performed
排除标准
- •Use of the following medications:
- •Daily use of steroids or aspirin ≥ 700 mg per week
- •Immunosuppressive treatment
- •Thiazolidinediones
- •Concomitant treatment with any other therapeutic antibody, or treatment with any biologic agent that blocks the IL-1 or TNFα signaling pathway
- •Change in medication for diabetes within 28 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total
- •Hemoglobin <10.0 g/dL, WBC <3.0 x 103/mm3 , platelet count <125 x 103/mm3, creatinine > 1.5mg/dL, AST/ALT >2 x ULN, alkaline phosphatase >2 x ULN
- •Abnormal, untreated T3, T4, thyroglobulin, or TSH levels or history of Grave's disease
- •Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody
- •History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, nonmetastatic squamous or basal cell carcinoma of the skin
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma
- •Infectious disease:
- •CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
- •History of recurrent infection or predisposition to infection
- •Active leg or foot ulcer
- •Immunodeficiency
- •Female patients who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
- •Receipt of a live (attenuated) vaccine within 3 months prior to Screening
- •Major surgery within 28 days prior to Day 0
- •Participation in an investigational drug or device trial within 30 days prior to Screening
研究组 & 干预措施
T2-18C3 therapeutic antibody
Experimental
9 subjects will receive the T2-18C3 therapeutic antibody.
干预措施: T2-18C3 therapeutic antibody (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 90 days
The safety and tolerability of T2-18C3 will be determined by observing patients for clinical adverse events, changes in vital signs, and changes in laboratory parameters such as hematology and chemistry.
次要结局
- Preliminary Efficacy(90 days)
- Pharmacokinetics(90 days)
研究者
研究点 (1)
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