Phase 1 Study of GXV-001 in Australia: Start of Repeated-Dose Study

GEXVal Inc.
February 15, 2023

GEXVal Inc., through its wholly-owned subsidiary GEXVal AU Pty Ltd., is conducting a Phase I clinical trial in Australia for the drug candidate GXV-001. Approval from the Safety Review Committee (SRC) was obtained after completing the single-dose study. Since then, we have been recruiting subjects for the repeated-dose study. We are pleased to announce that the first dose of the first patient has been completed, and the study has been commenced.

The study is entitled “A Two-Part, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of GXV-001 in Healthy Volunteers.” It aims to investigate the safety, tolerability, and pharmacokinetics of GXV-001. This repeated-dose study will be conducted as a placebo-controlled, double-blind, dose-escalating study in healthy adults by selecting an appropriate dose from the results of the single-dose study.

GEXVal strives to generate extra value to deliver cost-effective, innovative treatment options to improve health and QoL of patients and families affected by rare and intractable diseases.


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