[Translation] A Phase 1b/2 clinical study evaluating the tolerability, safety, pharmacokinetics, pharmacodynamics, and efficacy of recombinant humanized monoclonal antibody MIL62 injection in subjects with lupus nephritis
1b期,主要目的:
评价不同剂量和给药频次的MIL62在狼疮性肾炎受试者中的耐受性,确定最大耐受剂量和2期临床研究剂量和给药频次。
2期,主要目的:
评价与比较MIL62联合标准疗法和安慰剂联合标准疗法治疗狼疮性肾炎76周的完全肾脏缓解率。
[Translation] Phase 1b, main purpose:
Evaluate the tolerability of MIL62 at different doses and dosing frequencies in subjects with lupus nephritis, determine the maximum tolerated dose and the dose and dosing frequency for Phase 2 clinical studies.
Phase 2, main purpose:
Evaluate and compare the complete renal remission rate of MIL62 combined with standard therapy and placebo combined with standard therapy in the treatment of lupus nephritis for 76 weeks.