Asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: MEDI9929/AMG157
Product Code: MEDI9929
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pending
CAS Number: 1572943-04-4
Current Sponsor code: MEDI9929/AMG157
Concentrati
Sponsors
MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 in adolescent subjects with mild to moderate asthma.;Secondary Objective: 1. To evaluate the safety and tolerability of MEDI9929 2. To evaluate the immunogenicity of MEDI9929;Primary end point(s): The primary endpoint for this study is MEDI9929 PK parameters: area under the time-concentration curve from zero to infinity and to last observation (AUC(0-infinity) and AUC(0-t), respectively); dose-normalized AUC(0-infinity) (AUC(0 infinity)/D); maximum observed serum concentration (Cmax); dose-normalized Cmax (Cmax/D); time to reach C max ( tmax); terminal elimination half-life ( t1/2z); apparent clearance (CL/F); and apparent steady-state volume of distribution (Vss/F).;Timepoint(s) of evaluation of this end point: There will be 11 PK assessments from administration of investigational product up to, and including, Day 85. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety parameters: treatment-emergent adverse events, vital signs, physical examination, laboratory measurements, and electrocardiogram (ECG) 2. Immunogenicity: anti-drug antibodies (ADAs) to MEDI9929;Timepoint(s) of evaluation of this end point: Secondary endpoint will be measured up to Day 85 | — |
Countries
Poland
Contacts
Public ContactJacki Sorrells
MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)
Outcome results
None listed