781: Bioequivalence and Efficacy Study of Mb-102 With Transdermal GFR Measurement in Chinese Subjects

Introduction: To address the clinical need for non-invasive, real-time glomerular filtration rate (GFR) assessment, this study evaluated the bioequivalence (BE), efficacy, and safety of MB-102 plus MediBeacon® Transdermal GFR Monitoring System (TGFR) in Chinese individuals with normal or impaired renal function. Methods: This study (NCT05943977) comprised two parts. Part I was a randomized, crossover BE study comparing domestic manufactured MB-102 (MB-102DMS) with oversea manufactured formulation (MB-102OMS) in healthy volunteers. Part II was an open-label trial evaluating the efficacy and safety of MB-102DMS with TGFR. Subjects were stratified by baseline estimated GFR (eGFR) into Cohort 1 (≥70 mL/min/1.73m2) and Cohort 2 (< 70 mL/min/1.73m2). All participants received 130 mg MB-102 intravenously. Plasma GFR (nGFR) was calculated using a two-compartment pharmacokinetic (PK) model, while transdermal GFR (tGFR) was continuously monitored by TGFR. The primary endpoints were AUC₀–∞ (Part I) and P30, the proportion of tGFR values within ±30% of body surface area-indexed plasma GFR (nGFRBSA) (Part II). Secondary endpoints in Part II included PK and safety. Results: Part I enrolled 24 subjects. Part II included 97 subjects, with 91 comprising the modified intent-to-measure set (mITMS). The geometric mean ratio of AUC₀-∞ for MB-102DMS versus MB-102OMS was 100.5% (90%CI: 98.35-102.73), within the accepted BE range (80.00-125.00%). In Part II, overall P30 was 97.8% (95%CI: 92.29-99.73), exceeding the prespecified threshold (lower CI >85%). P30 values were 100.0% (95% CI: 92.13-100.0) in Cohort 1 and 95.7% (95% CI: 85.16-99.47) in Cohort 2. Intraclass correlation coefficients between tGFR and nGFRBSA were 0.961 (mITMS), 0.750 (Cohort 1), and 0.959 (Cohort 2). Bland-Altman analysis showed mean differences of 1.15 (mITMS), 0.03 (Cohort 1), and 2.25 mL/min/1.73m2 (Cohort 2). PK analysis showed lower clearance, prolonged half-life, and higher AUC in Cohort 2 versus Cohort 1. Treatment-related adverse events (AEs) occurred in < 2% of subjects and were not attributed to MB-102 or TGFR. No serious AEs were reported. Conclusions: MB-102DMS demonstrated BE to MB-102OMS. The combination with TGFR provided a safe, non-invasive, and reliable approach for dynamic GFR monitoring.