A Phase 1 interventional study of AbGn168 intravenous infusion and AbGn168 intravenous infusion in Psoriasis, sponsored by Boehringer Ingelheim. Completed at 7 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-01.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
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
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
AbGn168 cohort 1
Drug: AbGn168 intravenous infusion
AbGn168 cohort 2
Drug: AbGn168 intravenous infusion
AbGn168 cohort 3
Drug: AbGn168 intravenous infusion
AbGn168 cohort 4
Drug: AbGn168 intravenous infusion
AbGn168 cohort 5
Drug: AbGn168 intravenous infusion
AbGn168 cohort 6
Drug: AbGn168 intravenous infusion
AbGn168 cohort 7
Drug: AbGn168 intravenous infusion
AbGn168 cohort 8
Drug: AbGn168 subcutaneous injection
single dose intravenous infusion
single dose intravenous infusion
single dose intravenous infusion
single dose intravenous infusion
single dose intravenous infusion
single dose intravenous infusion
single dose intravenous infusion
single dose subcutaneous injection
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events
Time frame: Baseline, on treatment,and at end of study
Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy
Time frame: Baseline and on treatment
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim