[Translation] A Phase 1b/2 clinical study to evaluate the tolerability, safety, pharmacokinetics, pharmacodynamics and efficacy of recombinant humanized monoclonal antibody MIL62 injection in lupus nephritis subjects
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:
To evaluate the tolerability of different doses and dosing frequencies of MIL62 in subjects with lupus nephritis, to determine the maximum tolerated dose and the dose and dosing frequency of phase 2 clinical studies.
Phase 2, the main purpose:
To evaluate and compare 76-week complete renal remission rates in lupus nephritis with MIL62 combined with standard therapy and placebo combined with standard therapy.