A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.

Asthma Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-controlled, Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Mild Atopic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928368
• Other study ID #: 20110235
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2013
• Last updated: December 13, 2016
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy subjects and subjects with mild atopic asthma.

Description:

A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria (All subjects)

• Is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is =10 pack years.

• Females must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; OR history of hysterectomy; OR history of bilateral salpingectomy; OR history of bilateral oophorectomy).

• Body mass index (BMI) between = 18.0 and = 32.0 kg/m2 at screening. (Subjects with mild atopic asthma only)

• Documented history of mild, stable atopic asthma within 2 years of screening.

• Has used only inhaled short-acting ß2-agonists (less than twice weekly) to treat asthma.

• Pre-bronchodilator forced expiratory volume in 1 second (FEV1) > 70% predicted at screening.

Exclusion Criteria

(All subjects)

• History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Principal Investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

• Subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (PPD) or QuantiFERON test at screening. Subjects with a documented negative PPD or QuantiFERON test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.

• Has donated or lost = 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP.

Other criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AMG 282
Single dose either subcutaneously or intravenously on day 1.
• AMG 282 Matching Placebo
Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.

Locations

Country	Name	City	State
United States	Research Site	Aventura	Florida
United States	Research Site	Cypress	California
United States	Research Site	Lenexa	Kansas
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of various pharmacodynamic biomarkers in subjects with mild atopic asthma		Up to day 141	No
Primary	Incidence of treatment emergent adverse events		Up to day 141	Yes
Primary	Incidence of abnormal clinically significant vital signs		Up to day 141	Yes
Primary	Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results		Up to day 141	Yes
Primary	Incidence of abnormal clinically significant ECG results		Up to day 141	Yes
Primary	Incidence of anti-AMG 282 antibodies		Up to 1 year	Yes
Secondary	Determination of various PK parameters including tmax, AUClast and Cmax		Up to day 141	No

External Links

•   AmgenTrials clinical trials website