A Study to Evaluate the Pharmacokinetics of MEDI9929 (AMG 157) in Adolescents With Mild to Moderate Asthma

NCT ID: NCT02512900

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-10
• Study Completion Date: 2016-05-17

Brief Summary

To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.

Detailed Description

The primary objective is to evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma. The secondary objective is to evaluate the safety and tolerability of MEDI9929 and to evaluate the immunogenicity of MEDI9929 (AMG 157). The exploratory objective is to evaluate the effect of MEDI9929 (AMG 157) on pulmonary function

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MEDI9929, 140 mg, Cohort 1 (12 to 14 years)

On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 12 to 14 years of age.

Group Type: EXPERIMENTAL

MEDI9929, 140 mg

Intervention Type: DRUG

On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age.

MEDI9929, 140 mg, Cohort 2 (15 to 17 years)

On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 15 to 17 years of age.

Group Type: EXPERIMENTAL

MEDI9929, 140 mg

Intervention Type: DRUG

On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age.

Interventions

MEDI9929, 140 mg

On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age.

Intervention Type: DRUG

Other Intervention Names

Subcutaneous single-dose

Eligibility 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.
• Physician prescribed daily use of asthma controller medication
• Prebronchodilator FEV1 of ≥ 70% of predicted normal value at screening.
• A postbronchodilator increase in FEV1 ≥ 12% and ≥ 200 mL at screening.
• If on allergen immunotherapy, subjects must be on a stable maintenance dose and schedule ≥ 1 month prior to Visit 1.
• 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
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from screening
• Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from screening

Exclusion Criteria

• History of a deterioration in asthma that required a burst of systemic corticosteroids within 3 months of screening, up to and including Day 1.
• Clinical characteristics at either screening or Day 1 that are consistent with uncontrolled asthma as described in GINA guideline.
• History of hospitalization (overnight admission) for asthma during the 6 months prior to screening.
• 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.
• History of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
• 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).
• Pregnant or breastfeeding females.
• Current tobacco smoking or cessation of smoking for ≤ 6months prior to screening.
• Any clinically relevant abnormal findings which in the opinion of the investigator 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.
• Evidence of active liver disease,
• Positive hepatitis B or hepatitis C virus
• A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications
• Major surgery within 8 weeks prior to Visit 1, or planned in-patient surgery or hospitalization during the study period.
• History of any known primary immunodeficiency disorder
• History of a clinically significant infection
• A helminth parasitic infection within 24 weeks of Visit 1 that has not been treated or has not responded to standard of care therapy.
• History of cancer.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rene van der Merwe, MBChB, MSc, FFPM

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Research Site

Kielce, , Poland

Research Site

Lodz, , Poland

Research Site

Wroclaw, , Poland

Research Site

Wroclaw, , Poland

Countries

Poland

Other Identifiers

2014-005450-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D5180C00002

Identifier Type: -

Identifier Source: org_study_id