A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 12/15/2016 |
Start Date: | August 2013 |
End Date: | March 2016 |
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.
subjects and subjects with mild atopic asthma.
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.
atopic asthma will exhibit an acceptable safety and tolerability profile within the dose
ranges studied.
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.
We found this trial at
5
sites
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
