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

NCT ID: NCT01258205

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-02-18

Brief Summary

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).

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part B

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

Group Type: EXPERIMENTAL

AMG 139

Intervention Type: DRUG

Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).

Part A

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

Group Type: EXPERIMENTAL

AMG 139

Intervention Type: DRUG

Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).

Interventions

AMG 139

Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).

Intervention Type: DRUG

Eligibility Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Comprehensive Clinical Research

Berlin, New Jersey, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Virginia Commonwealth University

Richmond, Virginia, United States

QPharm Pty Limited

Herston, Queensland, Australia

Clinical Medical and Analytical eXellence CMAX

Adelaide, South Australia, Australia

Centre for Clinical Studies (Alfred)

Prahran, Victoria, Australia

Countries

United States; Australia

Other Identifiers

20090519

Identifier Type: -

Identifier Source: org_study_id