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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: AMG 139


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amgen, AMG 139, Crohn's Disease