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

Amgen

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Drug: AMG 282

Drug: AMG 282 Matching Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01928368

20110235

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.