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

Phase 1

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: AMG 139

• Registration Number: NCT01258205
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Study Start: 2011-02-28
• Primary Completion: 2015-02-18
• Study Completion: 2015-02-18
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B	AMG 139	One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.
Part A	AMG 139	Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

QPharm Pty Limited; 🇦🇺 Herston, Queensland, Australia

Clinical Medical and Analytical eXellence CMAX; 🇦🇺 Adelaide, South Australia, Australia

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

Centre for Clinical Studies (Alfred); 🇦🇺 Prahran, Victoria, Australia