AMG 761 in Adults With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:December 2011
End Date:December 2012
Contact:Amgen Call Center
Phone:886-572-6436

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A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 761 in Subjects With Asthma


The purpose of this study is to determine that no significant safety issues will be
identified following a single dose of AMG 761 in asthma subjects that would preclude further
development of AMG 761.


Inclusion Criteria:

- Healthy, with no history or evidence of clinically relevant medical or psychiatric
disorders (with the exception of asthma) as determined by the investigator in
consultation with the Amgen physician where medically appropriate

- Immunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/Tdap),
pneumococcal (polysaccharide), influenza (during flu season) and H1N1 (where and when
available) vaccinations, as determined by the principal investigator

- Body mass index (BMI) in the range of 18 to 35 kg/m2, inclusive

- Is a current non-smoker and has not used any tobacco products within the last 6
months and the cumulative smoking history must be ≤ 10 pack years

- Clinically stable with a physician diagnosis of asthma for a minimum of 6 months
prior to enrollment, and with no change in asthma treatment for at least 3 months
prior to enrollment. As needed beta-agonist use (ie, PRN) should be considered a
stable treatment

- Documented history of atopy to oak, mite, ragweed, timothy grass, Alternaria mold,
kochia pollen, aspergillus, or cottonwood within 18 months or positive atopy skin
prick test for these specific allergens during the screening period

- Additional inclusion criteria apply

Exclusion Criteria:

- Past history of serious skin rash requiring hospitalization

- Active, or history of (within 12 months of enrollment), acute viral infection of the
skin (eg, herpes simplex, herpes zoster, or molluscum contagiosum)

- Active or history of psoriasis, or a first degree relative with active or known
history of psoriasis

- First degree relatives with active or history of systemic lupus erythematosus or type
1 diabetes, rheumatoid arthritis or other active autoimmune disorder, as determined
by the principal investigator

- History of life-threatening anaphylaxis

- Experienced an asthma exacerbation (defined as a disease episode resulting in
treatment in an emergency room, hospitalization, or an episode treated with oral
corticosteroids in dosage of at least 5 mg/day prednisone or equivalent for ≥ 1 week)
during the 6 months prior to enrollment

- Additional exclusion criteria apply
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