Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis

This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study). The first part has a total of 3 dose groups, with 10 subjects enrolled in each dose group. Subjects are randomly assigned to receive MIL62 combined with standard of care or placebo combined with standard of care at a 4:1 ratio. Based on the tolerability, safety, pharmacodynamics, pharmacokinetics, and preliminary efficacy of the 3 dose groups, the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dosing frequency will be determined. Part B is open-label, enrolling 10 subjects who will receive the recommended dose of MIL62 combined with standard of care.

NCT Number	NCT07044115
Lead Sponsor	Beijing Mabworks Biotech Co., Ltd.
Conditions	Lupus Nephritis
Enrollment	41 participants
Start Date	2021-11-26
Primary Completion	2025-01-16 (estimated)
Study Completion	2025-08 (estimated)
Updated on ClinicalTrials.gov	2025-07-02