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

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