Clinical trial NCT01928368: A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Mild asthma
Atopic asthma
Healthy volunteers
First-in-human
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-08-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 β2-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.

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: Up to day 141
measure: Incidence of abnormal clinically significant vital signs
timeFrame: Up to day 141
measure: Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
timeFrame: Up to day 141
measure: Incidence of abnormal clinically significant ECG results
timeFrame: Up to day 141
measure: Incidence of anti-AMG 282 antibodies
timeFrame: Up to 1 year
Secondary outcomes:
measure: Determination of various PK parameters including tmax, AUClast and Cmax
timeFrame: Up to day 141
Other outcomes:
measure: Measurement of various pharmacodynamic biomarkers in subjects with mild atopic asthma
timeFrame: Up to day 141
Locations:
city: Cypress
country: United States
facility: Research Site
state: California
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Lenexa
country: United States
facility: Research Site
state: Kansas
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: