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Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.

NCT01290042 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2015-03-17

No results posted yet for this study

Summary

To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Conditions

Interventions

DRUG

AMG 181

Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

OTHER

Placebo for AMG 181

Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290042 on ClinicalTrials.gov