Clinical-stage biotechnology company ReviR Therapeutics announced on Monday that the first participant has been dosed in the First-in-Human (FIH) Phase 1 clinical trial of its lead candidate, RTX-117.
This clinical progress follows the recent clearance by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) of Investigational New Drug (IND) applications for two rare neurological indications: Charcot-Marie-Tooth disease (CMT) and Vanishing White Matter disease (VWM). The pipeline has also received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA), enabling the expansion of its clinical programme into the United States.
The Phase 1 study is a randomised, double-blind, placebo-controlled, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of RTX-117 in healthy participants, supporting the transition into subsequent clinical trials for patients with CMT and VWM.
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