Discussion
dizziness, PD, RA, leukopenia
DISEASE, UPPER RESPIRATORY TRACT INFECTION, LEUKOPENIA
In this phase Ia, randomized, placebo-controlled study, the analysis of safety data revealed an acceptable safety profile for WBP216 in 10- to 300-mg single dose. The most common AEs observed in this study included upper respiratory tract infection, increase in aspartate aminotransferase levels, alanine aminotransferase levels, blood alkaline phosphatase levels, blood creatine phosphokinase levels, blood thyroid stimulating hormone, and reticulocyte percentage, decrease in neutrophil count, hemoglobin, and white blood cell count, leukopenia, and dizziness, which is similar to other agents targeting IL-6 (With the increase in dose of WBP216, the AUCIn a multicenter study, IL-6 levels increased after tocilizumab administration in patients with RA, reaching a maximum on day 4; levels then decreased slowly with repeated dosing (ACR20 and ACR50 responses were observed in all groups, but no substantial change was observed in the placebo group. Due to the limited sample size in our study, it was difficult to interpret the efficacy of WBP216 based on the results of ACR response. A decrease in DAS28 scores was observed in all WPB216 dose groups, but there was no substantial change in the placebo group. The decrease was more remarkable in ≥30-mg groups than in 10 mg. This suggests that WBP216 had potential effect to decrease the disease activity in RA subjects, but it still needs further validation with more subjects to determine the most appropriate dosage.This was the first clinical study to evaluate the safety, tolerability, PK, PD, and immunogenicity of WBP216 in the Chinese population. The acceptable safety profile and longer t