Successfully Completed Phase I Single Dose Study for GXV-001
January 10, 2023
GEXVal Inc. is conducting a Phase I study for GXV-001, a new drug candidate, through our 100% owned subsidiary, GEXVal AU Pty Ltd. We are pleased to announce that we have completed single ascending dose study and held Safety Review Committee (SRC) meeting.
This study is entitled “A Two-Part, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GXV-001 in Healthy Volunteers.” It aims to investigate the safety, tolerability, and pharmacokinetics of GXV-001. The single ascending dose study was conducted as a placebo-controlled, double-blind study in 39 healthy adults at five dose levels.
Upon completion of SAD, SRC acknowledges that no serious adverse event was reported in any dose group of GXV-001 and the pharmacokinetic profile is excellent with good linearity. Moreover, this study also measured “Proof of Mechanism” (POM, confirmation of mechanism of action) readouts, i.e. molecular biomarker as well as physiological response as exploratory endpoints. Pharmacological meaningful effects against drug target were observed in all GXV-001 dose groups.
Based on these results, SRC approves proceeding to multiple ascending dose study. Furthermore, dose arms for the multiple ascending dose study were also discussed and determined. GEXVal AU Pty Ltd. will proceed to conduct the placebo-controlled, double-blind, multiple ascending dose study in healthy adults.
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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