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
Overview
- Phase
- Phase 1
- Intervention
- AMG 282
- Conditions
- Asthma
- Sponsor
- Amgen
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Incidence of treatment emergent adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental Arm
Intervention: AMG 282
Placebo Arm
Intervention: AMG 282 Matching Placebo
Outcomes
Primary Outcomes
Incidence of treatment emergent adverse events
Time Frame: Up to day 141
Incidence of abnormal clinically significant vital signs
Time Frame: Up to day 141
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Time Frame: Up to day 141
Incidence of abnormal clinically significant ECG results
Time Frame: Up to day 141
Incidence of anti-AMG 282 antibodies
Time Frame: Up to 1 year
Secondary Outcomes
- Determination of various PK parameters including tmax, AUClast and Cmax(Up to day 141)