AMG 761 in Adults With Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01514981
• Other study ID #: 20080451
• Status: Terminated
• Phase: Phase 1
• First received: December 19, 2011
• Last updated: April 16, 2014
• Start date: December 2011
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AMG 761
Single dose of AMG 761 on study day 1.
• Placebo
Single dose of placebo on study day 1.

Locations

Country	Name	City	State
United States	Research Site	Denver	Colorado
United States	Research Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	The number of subjects with anti-AMG 761 antibodies after a single dose of AMG 761.		16 weeks	Yes
Secondary	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	No
Secondary	The circulating CD4+ CCR4+ T cell count.		16 weeks	Yes

External Links

•   AmgenTrials clinical trials website