Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Crohn's Disease

Treatments: Drug: AMG 139

Study type: Interventional

Funder types: Industry

Identifiers

NCT01258205

20090519

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Part A - Healthy Subjects:

• Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
• Body mass index (BMI) between 18 and 32 kg/m2
• Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
• Additional inclusion criteria apply

Part B - Crohn's Subjects:

• Male or female subjects with CD between 18 to 55 years-of-age
• Body mass index (BMI) between 18 and 32 kg/m2
• Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of mild to severe CD
• Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months
• Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to or greater than 180 and equal to or less than 450
• Elevated fecal calprotectin and CRP
• Additional inclusion criteria apply

Exclusion criteria

Parts A - Healthy Subjects:

• 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 evaluation, procedures or completion;
• Recent or on-going infection(s)
• Underlying condition(s) that predisposes the subject to infections
• History of malignancy of any type
• Additional exclusion criteria apply

Part B only - Crohn's Subjects:

• 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 evaluation, procedures or completion;
• Recent or on-going infection(s)
• Underlying condition(s) that predisposes the subject to infections
• History of malignancy of any type
• Additional exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

Part B

Experimental group

Description:

One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.

Treatment:

Drug: AMG 139

Part A

Experimental group

Description:

Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.

Treatment:

Drug: AMG 139