A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of MEDI9929 in Adolescents with Mild to Moderate Asthma

MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)0 个研究点开始时间: 2015年5月20日最近更新: 2016年8月22日

适应症

试验速览

暂无简介。

•- Age 12 to 17 years (inclusive) at both screening and Day 1
•- Physician diagnosed asthma for a minimum of 6 months prior to screening.
•- Weight = 30 kg at both screening and Day 1
•- Body mass index for age at both screening and Day 1 that is between 5th and 95th percentile (Centers for Disease Control Growth Charts).
•- Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from screening, and must agree to continue using such precautions through Day 85, and as a precaution, for an additional 45 days; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
•- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85, and as a precaution, for an additional 45 days
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) no
•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

•- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
•- History of intubation for the management of a deterioration in asthma.
•- History of systemic corticosteroid use for the maintenance treatment of asthma within 3 months prior to screening.
•- Pregnant or breastfeeding females.
•- Current tobacco smoking or cessation of smoking for = 6months prior to screening.
•- Any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A.
•- Positive hepatitis B surface antigen or hepatitis C virus antibody serology. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll
•- A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject’s verbal report
•- History of cancer
•- Any active medical condition other than asthma, that in the opinion of the investigator and/or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study (subjects with atopic skin conditions and allergic rhinitis are permitted)

发起方

MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)