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

Asthma Clinical Trial

Official title:

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of MEDI9929 (AMG 157) in Adolescents With Mild to Moderate Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512900
• Other study ID #: D5180C00002
• Secondary ID: 2014-005450-19
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2015
• Last updated: July 8, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MEDI9929 (AMG 157)
MEDI9929 (AMG 157) (Investigational Product) - single dose

Locations

Country	Name	City	State
Poland	Research Site	Kielce
Poland	Research Site	Lódz
Poland	Research Site	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Amgen

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the effect of MEDI9929 (AMG 157) on pulmonary function	Lung function, including prebronchodilator forced expiratory volume in one second (FEV1)	85 days	Yes
Primary	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 primary endpoint for this study is MEDI9929 (AMG 157) 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 Cmax ( tmax); terminal elimination half-life ( t1/2z); apparent clearance (CL/F); and apparent steady state volume of distribution (Vss/F).	85 days	No
Secondary	The safety and tolerability of MEDI9929 (AMG 157)	Safety parameters: treatment-emergent adverse events, vital signs, physical examination, laboratory measurements, and electrocardiogram (ECG).	85 days	Yes
Secondary	The immunogenicity of MEDI9929 (AMG 157)	Evaluated by means of anti-drug antibodies (ADAs) to MEDI9929 (AMG 157).	85 days	No

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