Overview

This trial is active, not recruiting.

Condition asthma
Treatments amg 282, amg 282 matching placebo
Phase phase 1
Sponsor Amgen
Start date August 2013
End date March 2016
Trial size 70 participants
Trial identifier NCT01928368, 20110235

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
amg 282
Single dose either subcutaneously or intravenously on day 1.
(Placebo Comparator)
amg 282 matching placebo
Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.

Primary Outcomes

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

Secondary Outcomes

Measure
Determination of various PK parameters including tmax, AUClast and Cmax
time frame: Up to day 141

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Amgen.