Overview

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

Status:
Completed
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Collaborator:
MediBeacon