Study Complete
Sponsor ID
20090519

Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects

Sponsor ID
20090519
Clinicaltrials.gov ID
NCT01258205
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn’s disease (CD).

Additional Study Details

Phase
Phase 1
Product
AMG 139
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
48
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139

Timeframe: 36 weeks

Secondary Outcome Measures

Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD

Timeframe: 36 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Prahran, VIC, Australia, 3181
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Oklahoma City, OK, United States, 73102
Status
Recruiting
Location
Research Site
Berlin, NJ, United States, 08009
Status
Recruiting
Location
Research Site
Richmond, VA, United States, 23291
Status
Completed
Location
Research Site
Stony Brook, NY, United States, 11794
Status
Completed
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