Clinical trial NCT01514981: AMG 761 in Adults With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of treatment emergent adverse events per subject including clinically significant changes in vital signs, physical examinations, laboratory safety tests and ECGs.
timeFrame: 16 weeks
measure: The number of subjects with anti-AMG 761 antibodies after a single dose of AMG 761.
timeFrame: 16 weeks
Secondary outcomes:
measure: The maximum observed concentration, time to maximum concentration and the area under the serum concentration-time curve after a single dose of AMG 761.
timeFrame: 16 weeks
measure: The circulating CD4+ CCR4+ T cell count.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Miami
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: