NCT00541983已完成1 期
A Phase I, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin (HbA1c) at Days 0 and 28.
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of XOMA 052 in subjects with active Type 2 Diabetes Mellitus (T2D).
IV administration of XOMA 052 is likely to improve glycemic control in subjects with T2D by blocking certain receptors.
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)
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 T2D: Fasting blood glucose concentration ≥ 126 mg/dL (≥ 7.0 mmol/L) (must be measured within 28 days prior to Day 0) OR Symptoms of hyperglycemia (e.g., thirst, polyuria, weight loss, visual blurring) AND a casual/random plasma glucose value of ≥ 200 mg/dL (≥ 11.1 mmol/L) (must be measured within 28 days prior to Day 0)
- •HbA1c ≥ 7.5% and ≤ 12% (DCCT standard)
- •Current T2D of duration > 3 months and ≤ 10 years at Screening
- •T2D and other diseases must be stable. Stable disease is defined as disease that is judged stable by the investigator and which did not require a change in medications 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
- •Weight ≥ 80 lbs (36.3 kg) and ≤ 325 lbs (147.4 kg)
- •BMI ≥ 23 and ≤ 36 kg/m2
- •For female subjects of child-bearing age, a negative serum pregnancy test. For subjects with reproductive potential, a willingness to utilize adequate contraception 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
排除标准
- •Use of the following medications: Anti-inflammatory therapy other than aspirin ≤ 100 mg/day; Immunosuppressive treatment; Beta 2 and non-selective adrenergic blockers (Note: selective beta 1 blockers are permitted); Thiazolidinediones; Glucagon-like peptide (GLP) agonists including DPP4 inhibitors
- •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
- •Fasting C-peptide < 400 pM (< 1.20 μg/L)
- •Hemoglobin < 8.0 g/dL, WBC < 3.0 × 103/mm3, platelet count < 125 × 103/mm3, creatinine > 1.5 mg/dL, AST/ALT > 2 × ULN, alkaline phosphatase > 2 × ULN
- •Positive for GAD65 or IA-2 auto-antibodies
- •History or evidence of thyroid abnormalities, including active hyperthyroidism needing medication. Subjects with hypothyroidism will not be excluded if their TSH level has been normal during the 3 months prior to Screening.
- •Abnormal T3, T4, thyroglobulin, or TSH levels
- •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, non-metastatic 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 subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
- •History or symptoms of a demyelinating disease
- •Clinically significant diabetic macular edema and/or proliferative diabetic retinopathy by history or fundoscopy
- •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
- •Use of a therapeutic monoclonal antibody within 90 days prior to Screening
- •Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
研究组 & 干预措施
1
Active Comparator
干预措施: XOMA 052 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Glycated hemoglobin (HbA1c) at Days 0 and 28.
时间窗: Day 0 and Day 28
次要结局
- Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.(Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.)
- Safety assessed by adverse events, vital signs measurements, clinical laboratory assessments, infusion reactions, immune responses to XOMA 052.(Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.)
- Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.(Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.)
研究者
研究点 (1)
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