CLINICAL TRIALS PROFILE FOR MB-102
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Clinical Trials for MB-102
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02772276 ↗ | Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types | Completed | MediBeacon | Phase 2 | This study is a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different skin color types. |
| NCT03962998 ↗ | Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability | Recruiting | MediBeacon | Early Phase 1 | The objectives of the study are to evaluate the safety and tolerability of oral administration of MB-102, and to evaluate the use of MB-102 as a means of measuring gut permeability in normal participants (n=10) and in those with radiologic evidence of small bowel Crohn's disease (n=10). |
| NCT04109482 ↗ | Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN. | Recruiting | Mustang Bio | Phase 1/Phase 2 | A phase 1/2 study to assess the safety and efficacy of MB-102 in patients with relapsed or refractory BPDCN |
| NCT05425719 ↗ | Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects | Recruiting | MediBeacon | Phase 3 | This is a multi-center, open-label, pivotal study comparing transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) with MB-102 (relmapirazin) as the fluorophore. Participants will span the GFR range of values from normal to stage 4 chronic kidney disease (CKD) and span the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS). The safety and pharmacokinetics of MB-102 and the safety of the MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) will also be evaluated. |
| NCT05777174 ↗ | Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring | Not yet recruiting | MediBeacon | Phase 3 | The objective of this study is to establish that the MB-102 transdermal fluorescence-measured Glomerular Filtration Rate (GFR) using the MediBeacon® Measurement System with the Transdermal Glomerular Filtration Rate (TGFR) reusable sensor with disposable adhesive ring is comparable to the plasma-measured MB-102 GFR in normal and compromised renal function participants with different skin color types. |
| NCT05943977 ↗ | A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants | Completed | MediBeacon | Phase 3 | Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Part II (efficacy) will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese participants. |
| NCT05943977 ↗ | A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants | Completed | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Phase 3 | Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Part II (efficacy) will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese participants. |
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