A Clinical Study to Investigate the Effects of MEDI9929, a Drug Under Investigation, in Adolescents with Mild to Moderate Asthma

• Register: EUCTR
• Last refreshed on: 22 August 2016
• Main ID: EUCTR2014-005450-19-PL
• Date of registration: 20/05/2015
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)
• Public title: A Clinical Study to Investigate the Effects of MEDI9929, a Drug Under Investigation, in Adolescents with Mild to Moderate Asthma
• Scientific title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of MEDI9929 in Adolescents with Mild to Moderate Asthma
• Date of first enrolment: 27/07/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005450-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Poland

Contacts

• Name: Jacki Sorrells
• Affiliation: MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)

• Name: Jacki Sorrells
• Affiliation: MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)

Key inclusion & exclusion 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:
- 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Asthma
MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-

Primary Outcome(s)

Secondary Objective: 1. To evaluate the safety and tolerability of MEDI9929
2. To evaluate the immunogenicity of MEDI9929

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.

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 Outcome(s)

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

Secondary ID(s)

D5180C00002

Source(s) of Monetary Support

MedImmune LLC