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A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928368
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy subjects and subjects with mild atopic asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: AMG 282 Drug: AMG 282 Matching Placebo Phase 1

Detailed Description:
A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-controlled, Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Mild Atopic Asthma
Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Experimental Arm Drug: AMG 282
Single dose either subcutaneously or intravenously on day 1.

Placebo Comparator: Placebo Arm Drug: AMG 282 Matching Placebo
Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: Up to day 141 ]
  2. Incidence of abnormal clinically significant vital signs [ Time Frame: Up to day 141 ]
  3. Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results [ Time Frame: Up to day 141 ]
  4. Incidence of abnormal clinically significant ECG results [ Time Frame: Up to day 141 ]
  5. Incidence of anti-AMG 282 antibodies [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Determination of various PK parameters including tmax, AUClast and Cmax [ Time Frame: Up to day 141 ]

Other Outcome Measures:
  1. Measurement of various pharmacodynamic biomarkers in subjects with mild atopic asthma [ Time Frame: Up to day 141 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (All subjects)

  • Is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
  • Females must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; OR history of hysterectomy; OR history of bilateral salpingectomy; OR history of bilateral oophorectomy).
  • Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (Subjects with mild atopic asthma only)
  • Documented history of mild, stable atopic asthma within 2 years of screening.
  • Has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
  • Pre-bronchodilator forced expiratory volume in 1 second (FEV1) > 70% predicted at screening.

Exclusion Criteria

(All subjects)

  • History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Principal Investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  • Subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (PPD) or QuantiFERON test at screening. Subjects with a documented negative PPD or QuantiFERON test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
  • Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP.

Other criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928368


Locations
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United States, California
Research Site
Cypress, California, United States, 90630
United States, Florida
Research Site
Aventura, Florida, United States, 33180
United States, Kansas
Research Site
Lenexa, Kansas, United States, 66219
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27612
United States, Washington
Research Site
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01928368    
Other Study ID Numbers: 20110235
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Keywords provided by Amgen:
Mild asthma
Atopic asthma
Healthy volunteers
First-in-human
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases