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

NCT01258205 | Completed Phase 1

• 1 other identifier: 20090519
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 7

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

Keywords

Amgen; AMG 139; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Part B

EXPERIMENTAL

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

Drug: AMG 139

Part A

EXPERIMENTAL

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

Drug: AMG 139

Interventions

AMG 139 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; Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73102, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23291, United States

Location

QPharm Pty Limited

Herston, Queensland, 4029, Australia

Location

Clinical Medical and Analytical eXellence CMAX

Adelaide, South Australia, 5000, Australia

Location

Centre for Clinical Studies (Alfred)

Prahran, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

AMG 139

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: February 28, 2011
• Primary Completion: February 18, 2015
• Study Completion: February 18, 2015
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (4); AU (3)