A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

Amgen1 site in 1 country72 target enrollmentJuly 2010

ConditionsUlcerative Colitis

InterventionsAmg 181

DrugsAmg 181

Overview

Phase: Phase 1
Intervention: Amg 181
Conditions: Ulcerative Colitis
Sponsor: Amgen
Enrollment: 72
Locations: 1
Primary Endpoint: 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)
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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)

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

March 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Volunteers
•Healthy male or female subjects of non-reproductive potential between 18 to 45 year-of -age
•Body Mass Index (BMI) between 18 and 34 kg/m2
•Normal physical and neurological examination, clinical laboratory values and ECG
•Additional inclusion criteria apply
•Inclusion Criteria: Subjects with Mild to Moderate Ulcerative Colitis
•Male or female subjects between 18 to 55 year-of -age
•Body Mass Index (BMI) between 18 and 34 kg/m2
•Diagnosis of Ulcerative Colitis for at least 2 months
•Active, mild to moderate disease as defined by an Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 9 (inclusive), with a minimum sigmoidoscopy score of 1

Exclusion Criteria

Not provided

Arms & Interventions

Experimental

Ten escalating dose levels of AMG 181 administered as a single dose SC or IV in healthy volunteers and SC in subjects with mild-to-moderate ulcerative colitis.

Intervention: Amg 181

Outcomes

Primary Outcomes

Time Frame: Through study completion

Secondary Outcomes

To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181(Through study completion)
To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations(Through study completion)