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Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT01258205•AstraZeneca

View on ClinicalTrials.gov

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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
•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
+1 more criteria

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
•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

Locations (7)

Comprehensive Clinical Research

Berlin, New Jersey, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Virginia Commonwealth University

Richmond, Virginia, United States

QPharm Pty Limited

Herston, Queensland, Australia

Clinical Medical and Analytical eXellence CMAX

Adelaide, South Australia, Australia

Centre for Clinical Studies (Alfred)

Prahran, Victoria, Australia

Key Dates

Start Date

February 28, 2011

Primary Completion Date

February 18, 2015

Completion Date

February 18, 2015

Last Updated

May 10, 2021

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

AMG 139

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease