Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

NCT ID: NCT01094093

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-11
• Study Completion Date: 2011-07-26

Brief Summary

The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part B

Four dose levels of AMG 139 administered as a single dose SC or IV in subjects with moderate-severe psoriasis (Part B).

Group Type: EXPERIMENTAL

AMG 139

Intervention Type: DRUG

Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).

Part A

Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers.

Group Type: EXPERIMENTAL

AMG 139

Intervention Type: DRUG

Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).

Interventions

AMG 139

Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Part A - Healthy Volunteers:

• 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 - Psoriasis Subjects:

• Male or female of non-reproductive potential subjects with PsO 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 moderate to severe plaque PsO
• Diagnosis of plaque PsO for at least 6 months
• Moderate to severe plaque PsO defined by:
• A minimum PASI score of ≥ 10
• Psoriasis involving ≥ 10% of the Body Surface Area (BSA)

Exclusion Criteria

Parts A - Healthy Volunteers:

• 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, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years

Part B - Psoriasis 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
• Guttate, pustular, or other non-plaque forms of PsO
• Evidence of skin conditions other than PsO (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
• History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network Limited

Melbourne, Victoria, Australia

Clinical Medical and Analytical eXcellence (CMAX)

Adelaide, , Australia

QPharm Pty Limited

Herston, , Australia

Auckland Clinical Studies Ltd

Grafton, , New Zealand

Countries

Australia; New Zealand

Other Identifiers

20080767

Identifier Type: -

Identifier Source: org_study_id