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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: AMG 282; Drug: AMG 282 Matching Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Research Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Research Site
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98115
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Arm	Drug: AMG 282 Matching Placebo; Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.
ACTIVE_COMPARATOR: Experimental Arm	Drug: AMG 282; Single dose either subcutaneously or intravenously on day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment emergent adverse events	Up to day 141
Incidence of abnormal clinically significant vital signs	Up to day 141
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results	Up to day 141
Incidence of abnormal clinically significant ECG results	Up to day 141
Incidence of anti-AMG 282 antibodies	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Determination of various PK parameters including tmax, AUClast and Cmax	Up to day 141

Other Outcome Measures

Outcome Measure	Time Frame
Measurement of various pharmacodynamic biomarkers in subjects with mild atopic asthma	Up to day 141

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (ESTIMATE): August 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Healthy volunteers; First-in-human; Mild asthma; Atopic asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 20110235