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

Amgen

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Other: Placebo for AMG 181; Drug: AMG 181

Study type: Interventional

Funder types: Industry

Identifiers

NCT01290042

20101261

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

Placebo arm

Active Comparator group

Description:

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.

Treatment:

Other: Placebo for AMG 181

Active arm

Active Comparator group

Description:

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.

Treatment:

Drug: AMG 181