Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis

Study Overview
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Brief Summary
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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

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion (1 Mcg/kg, 5 Mcg/kg, 25 Mcg/kg, 125 Mcg/kg, 625 Mcg/kg, 3 mg/kg, or 10 mg/kg) or Subcutaneous Injection (625 Mcg/kg) to Patients With Chronic Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: AbGn168 intravenous infusion
* Drug: AbGn168 intravenous infusion
* Drug: AbGn168 intravenous infusion
* Drug: AbGn168 intravenous infusion
* Drug: AbGn168 intravenous infusion
* Drug: AbGn168 intravenous infusion
* Drug: AbGn168 intravenous infusion
* Drug: AbGn168 subcutaneous injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm 1<br>AbGn168 cohort 1 | Drug: AbGn168 intravenous infusion<br>* single dose intravenous infusion<br>|
| Experimental: arm 2<br>AbGn168 cohort 2 | Drug: AbGn168 intravenous infusion<br>* single dose intravenous infusion<br>|
| Experimental: arm 3<br>AbGn168 cohort 3 | Drug: AbGn168 intravenous infusion<br>* single dose intravenous infusion<br>|
| Experimental: arm 4<br>AbGn168 cohort 4 | Drug: AbGn168 intravenous infusion<br>* single dose intravenous infusion<br>|
| Experimental: arm 5<br>AbGn168 cohort 5 | Drug: AbGn168 intravenous infusion<br>* single dose intravenous infusion<br>|
| Experimental: arm 6<br>AbGn168 cohort 6 | Drug: AbGn168 intravenous infusion<br>* single dose intravenous infusion<br>|
| Experimental: arm 7<br>AbGn168 cohort 7 | Drug: AbGn168 intravenous infusion<br>* single dose intravenous infusion<br>|
| Experimental: arm 8<br>AbGn168 cohort 8 | Drug: AbGn168 subcutaneous injection<br>* single dose subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |