[Edaily Reporter Kim Hyung-il ] #Inventera Inc., a developer of medical imaging contrast agents, is set to begin a Phase 1 clinical trial in the U.S. for “INV-003 Solution,” a contrast agent specifically designed for magnetic resonance cholangiopancreatography (MRCP).

On the 17th, Inventera Inc. announced in a regulatory filing that it had submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial of INV-003 Solution. This trial will evaluate the safety, tolerability, and efficacy of INV-003 Solution in MRCP imaging following a single oral dose in clinically stable adults who require MRCP. The clinical trial will be conducted at one site in the U.S. for 12 months following IND approval, with a target enrollment of up to 30 participants.

MRCP is an examination that uses magnetic resonance imaging (MRI) to visualize the bile ducts and pancreatic ducts. Through this trial, Inventera Inc. plans to determine the maximum tolerated dose (MTD) of INV-003 solution and establish the recommended phase 2 dose (RP2D) for use in future Phase 2 clinical trials. During the trial, safety and tolerability will be evaluated by gradually increasing the dose following a single oral administration, and the presence of dose-limiting toxicity (DLT) as well as the efficacy of MRCP imaging will be assessed.