NCT07044115

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

A Phase 1b/2 Clinical Study Evaluating the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in Subjects With Lupus Nephritis

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Beijing Mabworks Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Recombinant Humanized Monoclonal Antibody MIL62 Injection	Phase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b.
DRUG	placebo	Phase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b.

Timeline

• Start date: 2021-11-26
• Primary completion: 2025-01-16
• Completion: 2025-08-01
• First posted: 2025-06-29
• Last updated: 2025-07-02

Locations

1 site across 1 country: China