[Translation] A multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation clinical study to evaluate the safety, pharmacokinetics and preliminary efficacy of FNS007 for injection in patients with rheumatoid arthritis
1.主要目的: 评价注射用FNS007在RA受试者中多次给药的安全性和耐受性 评价注射用FNS007在RA受试者中多次给药的药代动力学特征
2.次要目的 评价注射用FNS007在RA受试者中多次给药的初步疗效 评价注射用FNS007在RA受试者中的PK/PD特征 评价注射用FNS007在RA受试者中的免疫原性
[Translation] 1. Primary objectives: To evaluate the safety and tolerability of multiple administrations of FNS007 for injection in RA subjects To evaluate the pharmacokinetic characteristics of multiple administrations of FNS007 for injection in RA subjects
2. Secondary objectives To evaluate the preliminary efficacy of multiple administrations of FNS007 for injection in RA subjects To evaluate the PK/PD characteristics of FNS007 for injection in RA subjects To evaluate the immunogenicity of FNS007 for injection in RA subjects