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

Psoriasis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094093
• Other study ID #: 20080767
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2010
• Est. completion date: July 26, 2011

Study information

• Verified date: May 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 26, 2011
• Est. primary completion date: July 26, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

• Additional inclusion criteria apply

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)

• Additional inclusion criteria apply

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

• Additional exclusion criteria apply

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

• Additional exclusion criteria apply

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Australia	Clinical Medical and Analytical eXcellence (CMAX)	Adelaide
Australia	QPharm Pty Limited	Herston
Australia	Nucleus Network Limited	Melbourne	Victoria
New Zealand	Auckland Clinical Studies Ltd	Grafton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139		16-24 weeks
Secondary	Characterization of the pharmacokinetics (PK) of AMG 139		16-24 weeks
Secondary	Psoriasis Activity and Severity Index (PASI) scores (Part B only)		16-24 weeks