NCT01928368

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AMG 282	Single dose either subcutaneously or intravenously on day 1.
DRUG	AMG 282 Matching Placebo	Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-08-23
• Last updated: 2016-12-14

Locations

5 sites across 1 country: United States