NCT01160861已完成1 期
A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
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
- 主要终点
- Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
研究概览
简要总结
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (PK) of MEMP1972A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of allergic rhinitis
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- •Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug
排除标准
- •History or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
- •History of anaphylaxis, hypersensitivity or drug allergies
- •Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing
- •Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing
- •Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody
研究组 & 干预措施
A
Experimental
干预措施: MEMP1972A (Drug)
A
Experimental
干预措施: placebo (Drug)
B
Experimental
干预措施: MEMP1972A (Drug)
B
Experimental
干预措施: placebo (Drug)
C
Experimental
干预措施: MEMP1972A (Drug)
C
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
时间窗: Throughout study or until early discontinuation
Incidence, nature, and severity of adverse events
时间窗: Throughout study or until early discontinuation
次要结局
- Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)(Throughout study or until early discontinuation)
研究者
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