Terminated/Withdrawn
Sponsor ID
20090107

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects with Mild to Moderate Ulcerative Colitis

Sponsor ID
20090107
Clinicaltrials.gov ID
NCT01164904
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)

Additional Study Details

Phase
Phase 1
Product
AMG 181
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
72
Additional Study Details

Protocol Summary

Primary Outcome Measures

To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)

Timeframe: Through study completion

Secondary Outcome Measures

To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181

Timeframe: Through study completion

To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations

Timeframe: Through study completion

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Prahran, VIC, Australia, 3004
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Herston, QLD, Australia, 4006
Status
Recruiting
Location
Research Site
Nedlands, WA, Australia, 6009
Status
Completed
Location
Research Site
Auckland, New Zealand, 1023
Status
Completed
Location
Research Site
Christchurch, New Zealand, 8011
Status
Completed
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