A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.

Amgen1 site in 1 country43 target enrollmentFebruary 2011

ConditionsUlcerative Colitis Crohn's Disease

InterventionsPlacebo for AMG 181 AMG 181

DrugsAMG 181

Overview

Phase: Phase 1
Intervention: Placebo for AMG 181
Conditions: Ulcerative Colitis
Sponsor: Amgen
Enrollment: 43
Locations: 1
Primary Endpoint: To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

May 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body Mass Index (BMI) between 18 and 34 kg/m2
•Normal physical and neurological examination, clinical laboratory values and ECG
•Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subjects with ulcerative colitis)
•Crohn's Disease Activity Index (CDAI) score of \>150 and \< 450 at screening (for subjects with Crohn's disease)
•Additional inclusion criteria apply

Exclusion Criteria

•History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion
•History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years
•Underlying condition(s) that predisposes the subject to infections
•Disease limited to the rectum, i.e. within 10 cm of the anal verge (for subjects with ulcerative colitis)
•Evidence of severe disease (as evidenced by an Hb concentration less or equal to 10g/dL; toxic megacolon, or an UCDAI score greater than 10) (for subjects with ulcerative colitis)
•Subject has short bowel syndrome (for subjects with Crohn's disease)
•Presence of an ostomy (for subjects with Crohn's disease)
•Presence of a fistula (for subjects with Crohn's disease)
•Additional exclusion criteria apply

Arms & Interventions

Placebo arm

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.

Intervention: Placebo for AMG 181

Active arm

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.

Intervention: AMG 181

Outcomes

Primary Outcomes

To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Time Frame: 40 Weeks

Secondary Outcomes

To measure the area under the plasma concentration curve versus time of drug AMG 181.(29 Weeks)
To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181.(29 weeks)
To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181.(29 Weeks)