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

Phase 1

Completed

• Conditions: Ulcerative Colitis; Crohn's Disease
• Interventions: Other: Placebo for AMG 181; Drug: AMG 181

• Registration Number: NCT01290042
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-27
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo arm	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.
Active arm	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.

Primary Outcome Measures

Name	Time	Method
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.	40 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇦🇺 Prahran, Victoria, Australia