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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT01258205
• Date of registration: 09/12/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
• Scientific 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
• Date of first enrolment: February 28, 2011
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01258205
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Australia, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: AMG 139

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

20090519

Source(s) of Monetary Support

Please refer to primary and secondary sponsors