Study Complete
Sponsor ID
20110235

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

Sponsor ID
20110235
Clinicaltrials.gov ID
NCT01928368
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 282
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
70
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of treatment emergent adverse events

Timeframe: Up to day 141

Incidence of abnormal clinically significant vital signs

Timeframe: Up to day 141

Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

Timeframe: Up to day 141

Incidence of abnormal clinically significant ECG results

Timeframe: Up to day 141

Incidence of anti-AMG 282 antibodies

Timeframe: Up to 1 year

Secondary Outcome Measures

Determination of various PK parameters including tmax, AUClast and Cmax

Timeframe: Up to day 141

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Cypress, CA, United States, 90630
Status
Completed
Location
Research Site
Raleigh, NC, United States, 27612
Status
Completed
Location
Research Site
Lenexa, KS, United States, 66219
Status
Completed
Location
Research Site
Aventura, FL, United States, 33180
Status
Completed
Location
Research Site
Seattle, WA, United States, 98115
Status
Completed