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

Crohn's Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258205
• Other study ID #: 20090519
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2011
• Est. completion date: February 18, 2015

Study information

• Verified date: May 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 18, 2015
• Est. primary completion date: February 18, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Australia	Clinical Medical and Analytical eXellence CMAX	Adelaide	South Australia
Australia	QPharm Pty Limited	Herston	Queensland
Australia	Centre for Clinical Studies (Alfred)	Prahran	Victoria
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139		36 weeks
Secondary	Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD		36 weeks