A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants

PHASE3CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

March 2, 2023

Primary Completion Date

November 30, 2023

Study Completion Date

November 30, 2023

Conditions
Kidney DiseasesKidney InjuryKidney Failure
Interventions
DRUG

MB-102 DMID

130 mg of the MB-102 Domestic Manufactured Investigational Drug administered by intravenous injection over 30-60 seconds, followed by a 10 mL normal saline flush administered over 30-60 seconds.

DRUG

MB-102 OMID

130 mg of the MB-102 Overseas Manufactured Investigational Drug (OMID) administered by intravenous injection over 30-60 seconds, followed by a 10 mL normal saline flush administered over 30-60 seconds.

DEVICE

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

On treatment day, participants will have the TGFR sensor placed on their chests, and the MediBeacon Transdermal GFR Measurement System will be initiated to collect background fluorescence. When this is completed, participants will then receive a single dose of MB-102. Fluorescent measurements terminated by the system when a low signal-to-noise threshold is reached.

Trial Locations (2)

215008

Suzhou Municipal Hospital, Suzhou

221000

Affiliated hospital of Xuzhou Medical University, Xuzhou

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MediBeacon

INDUSTRY

lead

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

INDUSTRY