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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: AMG 139


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part B<br>Four dose levels of AMG 139 administered as a single dose SC or IV in subjects with moderate-severe psoriasis (Part B). | Drug: AMG 139<br>* 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).<br>|
| Experimental: Part A<br>Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers. | Drug: AMG 139<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 16-24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the pharmacokinetics (PK) of AMG 139 |  | 16-24 weeks | 
| Psoriasis Activity and Severity Index (PASI) scores (Part B only) |  | 16-24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amgen, AMG 139