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

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

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).

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: AMG 139

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4029
      • QPharm Pty Limited
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Clinical Medical and Analytical eXellence CMAX
  • Victoria
    • Prahran, Victoria, Australia, 3181
      • Centre for Clinical Studies (Alfred)
• United States
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Oklahoma Foundation for Digestive Research
  • Virginia
    • Richmond, Virginia, United States, 23291
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part B; One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.	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).
Experimental: Part A; Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2011
• Primary Completion (Actual): February 18, 2015
• Study Completion (Actual): February 18, 2015

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimate): December 10, 2010

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Crohn's Disease; Amgen; AMG 139
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 20090519