AMG 761 in Adults With Asthma

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: AMG 761; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • Research Site
  • Florida
    • Miami, Florida, United States, 33143
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single dose of placebo on study day 1.
Experimental: AMG 761	Drug: AMG 761; Single dose of AMG 761 on study day 1.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Antineoplastic Agents; Mogamulizumab
• Other Study ID Numbers: 20080451