EUCTR2010-021170-11-SE进行中（未招募）不适用
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OFINTRAVENOUS MEMP1972A IN THE PREVENTION OF ALLERGEN-INDUCED AIRWAY OBSTRUCTION IN PATIENTS WITH MILD ASTHMA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent
- •Men and women between 18 and 65 years old
- •Weight between 50 and 125 kg
- •Mild, stable allergic asthma
- •History of episodic wheeze and shortness of breath
- •FEV1 at baseline = 70% of the predicted value
- •Males or females who are surgically sterilized, post-menopausal for the past year, or are using two acceptable methods of contraception (excluding abstinence) against pregnancy through at least 5 months (predicted 5 half -lives of the study drug) following the last administration of study drug (see Appendix B for definitions of highly effective contraception)
- •ECG at screening within normal limits as assessed by the study investigator
- •Ability to comprehend and willingness to follow all required study procedures
- •Methacholine challenge at screening must be documented to confirm a
- •diagnosis of asthma and provide a PC20 value for prediction of the starting
- •allergen concentration for inhalation in the screening test for responsiveness
- •to allergen.
- •Positive skin prick test to common standard aeroallergens extracts
- •(e.g., ragweed, tree mix, grass mix, dog, cat, horse, feathers, dust mites)
- •Positive allergen-induced early and late airway response
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A worsening of asthma within 6 weeks preceding Visit 1
- •Acute respiratory infection (including viral infection) within 6 weeks preceding
- •Visit 2 or any ongoing chronic infection
- •History of recurrent bacterial infection as an adult or history or presence of any
- •chronic infectious condition, including (but not limited to) parasitic infection
- •Risk of exposure, as determined by the investigator, to water-borne parasites
- •or clinical diagnosis of parasitic infection that is untreated within 3 months
- •prior to Visit 5
- •Lung disease other than mild allergic asthma
- •History of clinically significant hypotensive episodes or symptoms of fainting,
- •dizziness, or lightheadedness
- •History or symptoms of cardiovascular disease, particularly coronary artery
- •disease, arrhythmias, hypertension, or congestive heart failure
- •History or symptoms of significant neurologic disease, including transient
- •ischemic attack, stroke, seizure disorder, or behavioral disturbances
- •History of significant hepatic or renal impairment
- •Evidence of an active or suspected cancer or history of treatment for cancer
- •History or symptoms of clinically significant autoimmune disease
- •Any acquired or congenital immune deficiency
- •Confirmed positive test for HIV or hepatitis B or C
- •Concomitant disease or condition, which could interfere with the conduct
- •of the study, or for which the treatment might interfere with the conduct
- •of the study, or which would, in the opinion of the investigator, poses an
- •unacceptable risk to the patients in this study, including, but not limited to
- •cancer, alcoholism, drug dependency or abuse, or psychiatric disease
- •History of serious adverse reaction or hypersensitivity to any drug
- •Clinically significant abnormal chest radiograph within the last 12 months
- •Clinically significant abnormalities in laboratory test results (including complete
- •blood count, coagulation, serum chemistry panel, and urinalysis)
- •Pregnancy or lactation or positive serum pregnancy test at screening
- •Use of corticosteroids (oral, systemic or inhaled), immunosuppressives,
- •anticoagulants (warfarin or heparin), or any medications that may interact
- •with study drug within 4 weeks prior to Visit 2
- •Chronic use of any other medication for treatment of allergic lung disease
- •other than short-acting ß2-agonists or ipratropium bromide
- •Use of cromoglycate, nedocromil, leukotriene receptor antagonists
- •(zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase
- •(zileuton) are not permitted within 4 weeks prior to Visit 2
- •Allergen or peptide immunotherapy within 6 months prior to Visit 1
- •Participation in any other investigational drug study within the preceding
- •30 days or 5 half-lives of that drug, whichever is longer at the time of Visit 2
- •Current (or history of) treatment with a monoclonal antibody or
- •chimeric biomolecule within the past 5 months (5 half-lives of the drug),
- •including omalizumab, at the time of Visit 2
- •Use of statins are not permitted within 4 weeks prior to Visit 2
- •Received live or attenuated vaccine (including but not limited to FluMist-brand influenza vaccine, MMR (measles, mumps, rubella), VZV (varicella zoster/chickenpox), oral polio, etc. within 30 days prior to Visit 5
- •Regular use of tobacco products of any kind or within the previous 6 months,
- •or smoking history > 10 pack-years
- •History of drug or alcohol abuse, which, in the judgment of the investigator,
- •may put the patient at risk for being unable to participate ful
研究者
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