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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01258205

Enrollment

Registered

2010-12-10

Start date

2011-02-28

Completion date

2015-02-18

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Amgen, AMG 139, Crohn's Disease

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).

Interventions

DRUGAMG 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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 * 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

Design outcomes

Primary

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

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

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026