[Edaily Reporter Minji Son ] #Inventera Inc. has received approval for its U.S. Phase 1 clinical trial plan for “INV-003 Solution,” an oral contrast agent specifically designed for magnetic resonance cholangiopancreatography (MRCP). The company plans to verify the drug’s safety and tolerability in the clinical trial and determine the dosage to be used in subsequent trials.

On the 19th, Inventera Inc. announced in a regulatory filing that it had received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for INV-003 Solution. The company submitted the IND application on the 17th of last month and received approval on the 16th of this month (local time).

This clinical trial will be conducted on clinically stable adults who require MRCP for follow-up observation or differential diagnosis. The trial is scheduled to enroll up to 30 participants at a single site in the United States.

Study participants will receive a single oral dose of INV-003 solution. The research team plans to evaluate safety and tolerability at different doses to determine the maximum tolerated dose (MTD) and establish the recommended Phase 2 dose. The visibility of the contrast agent in MRCP images will also be assessed.

The clinical trial is expected to last approximately 12 months from the start of the study, with the anticipated completion date announced as October 17 of next year. However, this is an estimated completion date and is subject to change.