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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: AMG 282; Drug: AMG 282 Matching Placebo

• Registration Number: NCT01928368
• Lead Sponsor: Amgen

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-23
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	AMG 282	-
Placebo Arm	AMG 282 Matching Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	Up to day 141
Incidence of abnormal clinically significant vital signs	Up to day 141
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results	Up to day 141
Incidence of abnormal clinically significant ECG results	Up to day 141
Incidence of anti-AMG 282 antibodies	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Determination of various PK parameters including tmax, AUClast and Cmax	Up to day 141

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States