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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

November 26, 2021

Primary Completion Date

January 16, 2025

Study Completion Date

August 31, 2025

Conditions
Lupus Nephritis
Interventions
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."

Trial Locations (1)

Unknown

Peking University People's Hospital, Beijing

All Listed Sponsors
lead

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY