This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Alliance Dermatology & MOHS Center, PC
Phoenix, Arizona, United States
Northwest AR Clinical Trials Center, PLLC.
Rogers, Arkansas, United States
75% reduction in the Psoriasis Area Severity Index (PASI 75)
The primary objective of this study is to investigate efficacy of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo.
Time frame: at week 10
Number of participants with abnormal Physical Examination finding
Time frame: At different time point for 20 weeks after the first treatment
Cmax
Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
Time frame: 12 weeks after the first treatment
Number of participants with Vital Sign change
Time frame: At different time point for 20 weeks after the first treatment
Number of participants with abnormal ECG finding
Time frame: At different time point for 20 weeks after the first treatment
Number of participants with abnormal Clinical Laboratory parameters
blood chemistry, hematology and urinalysis
Time frame: At different time point for 20 weeks after the first treatment
Number of participants with Adverse Event
Time frame: At different time point for 20 weeks after the first treatment
T1/2
Time frame: At different time point for 12 weeks after the first treatment
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