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AMG 761 in Adults With Asthma

This study has been terminated.
(Administrative decision)
Information provided by (Responsible Party):
Amgen Identifier:
First received: December 19, 2011
Last updated: April 16, 2014
Last verified: April 2014
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.

Condition Intervention Phase
Drug: AMG 761
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The number of treatment emergent adverse events per subject including clinically significant changes in vital signs, physical examinations, laboratory safety tests and ECGs. [ Time Frame: 16 weeks ]
  • The number of subjects with anti-AMG 761 antibodies after a single dose of AMG 761. [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • The maximum observed concentration, time to maximum concentration and the area under the serum concentration-time curve after a single dose of AMG 761. [ Time Frame: 16 weeks ]
  • The circulating CD4+ CCR4+ T cell count. [ Time Frame: 16 weeks ]

Enrollment: 7
Study Start Date: December 2011
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 761 Drug: AMG 761
Single dose of AMG 761 on study day 1.
Placebo Comparator: Placebo Drug: Placebo
Single dose of placebo on study day 1.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01514981

United States, Colorado
Research Site
Denver, Colorado, United States, 80206
United States, Florida
Research Site
Miami, Florida, United States, 33143
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT01514981     History of Changes
Other Study ID Numbers: 20080451
Study First Received: December 19, 2011
Last Updated: April 16, 2014

Keywords provided by Amgen:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 28, 2017