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

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AMG 139

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Amgen, AMG 139, Crohn's Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Comprehensive Clinical Research
Stony Brook University Medical Center
Oklahoma Foundation for Digestive Research
Virginia Commonwealth University
QPharm Pty Limited
Clinical Medical and Analytical eXellence CMAX
Centre for Clinical Studies (Alfred)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part B

Part A

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01258205

First Posted

December 9, 2010

Last Updated

May 6, 2021

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01258205

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

February 28, 2011 (Actual)

Primary Completion Date

February 18, 2015 (Actual)

Study Completion Date

February 18, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Amgen, AMG 139, Crohn's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part B

Arm Type

Experimental

Arm Description

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

Arm Title

Part A

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AMG 139

Intervention Description

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).

Primary Outcome Measure Information:

Title

Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139

Time Frame

36 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Comprehensive Clinical Research

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Stony Brook University Medical Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Oklahoma Foundation for Digestive Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73102

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23291

Country

United States

Facility Name

QPharm Pty Limited

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Clinical Medical and Analytical eXellence CMAX

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Centre for Clinical Studies (Alfred)

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

12. IPD Sharing Statement

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

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