AMG 761 in Adults With Asthma

This study has been terminated.
(Administrative decision)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01514981
First received: December 19, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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
Asthma
Drug: AMG 761
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
  • The number of subjects with anti-AMG 761 antibodies after a single dose of AMG 761. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • The circulating CD4+ CCR4+ T cell count. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514981

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

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01514981     History of Changes
Other Study ID Numbers: 20080451
Study First Received: December 19, 2011
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014