Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part B | Experimental | Four dose levels of AMG 139 administered as a single dose SC or IV in subjects with moderate-severe psoriasis (Part B). |
|
| Part A | Experimental | Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 139 | 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). |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Part A - Healthy Volunteers:
Part B - Psoriasis Subjects:
Exclusion Criteria:
Parts A - Healthy Volunteers:
Part B - Psoriasis Subjects:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Limited | Melbourne | Victoria | 3004 | Australia | ||
| Clinical Medical and Analytical eXcellence (CMAX) |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000600954 | AMG 139 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adelaide |
| SA500 |
| Australia |
| QPharm Pty Limited | Herston | 4006 | Australia |
| Auckland Clinical Studies Ltd | Grafton | 1010 | New Zealand |