Terminated/Withdrawn
Sponsor ID
20080451

AMG 761 in Adults with Asthma

Sponsor ID
20080451
Clinicaltrials.gov ID
NCT01514981
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to determine that no significant safety issues will be identified following a single dose of AMG 761 in asthma subjects that would preclude further development of AMG 761.

Additional Study Details

Phase
Phase 1
Product
AMG 761
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
7
Additional Study Details

Protocol Summary

Primary Outcome Measures

The number of treatment emergent adverse events per subject including clinically significant changes in vital signs, physical examinations, laboratory safety tests and ECGs.

Timeframe: 16 weeks

The number of subjects with anti-AMG 761 antibodies after a single dose of AMG 761.

Timeframe: 16 weeks

Secondary Outcome Measures

The maximum observed concentration, time to maximum concentration and the area under the serum concentration-time curve after a single dose of AMG 761.

Timeframe: 16 weeks

The circulating CD4+ CCR4+ T cell count.

Timeframe: 16 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Miami, FL, United States, 33143
Status
Recruiting
Location
Research Site
Denver, CO, United States, 80206
Status
Recruiting