Clinical trial NCT01258205: Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crohn's Disease
Keywords: Amgen
AMG 139
Crohn's Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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
* 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

Primary outcomes:
measure: Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
timeFrame: 36 weeks
Secondary outcomes:
measure: 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
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Herston
country: Australia
facility: QPharm Pty Limited
state: Queensland
city: Adelaide
country: Australia
facility: Clinical Medical and Analytical eXellence CMAX
state: South Australia
city: Prahran
country: Australia
facility: Centre for Clinical Studies (Alfred)
state: Victoria
Study officials:
References: