NCT01164904

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)

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2010

Typical duration for phase_1

Geographic Reach
3 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

2.5 years

First QC Date

July 1, 2010

Last Update Submit

July 23, 2013

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel DiseaseAmgen

Outcome Measures

Primary Outcomes (1)

  • 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)

    Through study completion

Secondary Outcomes (2)

  • 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

Study Arms (1)

Experimental

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.

Drug: Amg 181

Interventions

Amg 181DRUG

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

Experimental

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • Recent or on-going infection(s)
  • Underlying condition(s) that predisposes the subject to infections
  • Disease limited to the rectum, i.e. within 20 cm of the anal verge
  • Any prior gastrointestinal surgery
  • Evidence of severe disease (as evidenced by an Hb concentration \<11g/dL; toxic megacolon, or an UCDAI score≥10)
  • Immunosuppressive therapy with either azathioprine, methotrexate, or mercaptopurine, within the past 3 months
  • Prior exposure to a biologic agent or cyclosporine A
  • Use of antibiotics within the past 2 weeks of screening and during screening period
  • Use of topical (e.g. suppository or enema) mesalamine or steroids within two weeks prior to day 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Danbury, Connecticut, 06810, United States

Location

Research Site

Plymouth, Minnesota, 55446, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

Herston, Queensland, 4006, Australia

Location

Research Site

Adelaide, South Australia, 5000, Australia

Location

Research Site

Prahran, Victoria, 3004, Australia

Location

Research Site

Nedlands, Western Australia, 6009, Australia

Location

Research Site

Auckland, 1023, New Zealand

Location

Research Site

Christchurch, 8011, New Zealand

Location

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

abrilumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 19, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

NZ(2)US(4)AU(4)