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Unicycive Therapeutics Successfully Completes UNI-494 Phase 1 Study in Healthy Volunteers [Yahoo! Finance]

Unicycive Therapeutics, Inc. (UNCY) 
Company Research Source: Yahoo! Finance
“We are pleased to announce the successful completion of the UNI-494 Phase 1 study that informs our next steps for advancement to a potential Phase 2 clinical trial in patients with acute kidney injury,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This is an important milestone for the clinical development of UNI-494 as it provides the necessary dosing and tolerability data to progress the program. We plan to request a meeting with the U.S. Food and Drug Administration (FDA) before the end of the year to review these Phase 1 results and a potential Phase 2 study design. We would like to extend our gratitude to the trial investigator and participants who committed their time and effort to the study.” Trial Design: The Phase 1 study was a single center, double-blind, placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted in the United Kingdom. Dosing in both arms was completed in a st Show less Read more
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