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
Not provided
Not provided
The general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | AbGn168 cohort 1 |
|
| arm 2 | Experimental | AbGn168 cohort 2 |
|
| arm 3 | Experimental | AbGn168 cohort 3 |
|
| arm 4 | Experimental | AbGn168 cohort 4 |
|
| arm 5 | Experimental | AbGn168 cohort 5 |
|
| arm 6 | Experimental | AbGn168 cohort 6 |
|
| arm 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbGn168 intravenous infusion | Drug | single dose intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events | Baseline, on treatment,and at end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy | Baseline and on treatment |
Not provided
Inclusion criteria:
Patients with chronic plaque psoriasis covering at least 3% of body surface area. Female subjects must be postmenopausal or surgically sterilized.
Exclusion criteria:
Recent use of biologic agents, oral psoriasis medications or phototherapy
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1240.1.05 Boehringer Ingelheim Investigational Site | Boise | Idaho | United States | |||
| 1240.1.06 Boehringer Ingelheim Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
AbGn168 cohort 7 |
|
| arm 8 | Experimental | AbGn168 cohort 8 |
|
| AbGn168 intravenous infusion |
| Drug |
single dose intravenous infusion |
|
| AbGn168 intravenous infusion | Drug | single dose intravenous infusion |
|
| AbGn168 intravenous infusion | Drug | single dose intravenous infusion |
|
| AbGn168 intravenous infusion | Drug | single dose intravenous infusion |
|
| AbGn168 intravenous infusion | Drug | single dose intravenous infusion |
|
| AbGn168 intravenous infusion | Drug | single dose intravenous infusion |
|
| AbGn168 subcutaneous injection | Drug | single dose subcutaneous injection |
|
| Evansville |
| Indiana |
| United States |
| 1240.1.04 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States |
| 1240.1.02 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
| 1240.1.01 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 1240.1.03 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1240.1.7 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided