NanoViricides, Inc. reported that the Phase I Clinical Trial of NV-387 is completed successfully and data lock is expected soon. The Phase 1 clinical trial, protocol number KM-NVCoV2-001, which received approval from the regulatory agency in India for healthy as well as COVID-19 participants, was closed and completed in April by the Drug Sponsor and licensee, Karveer Meditech, Pvt. Ltd., and the CRO, PristynCR, in India.

The decision to close the clinical trial with healthy subjects study completed was taken because diligent efforts to identify suitable COVID-19 participants for the clinical trials were met with a notable absence of positive cases at the designated clinical trial sites, despite addition of a second site during January/February 2024. Both the single ascending dose part of this clinical trial (called Phase 1a), and the subsequent multiple ascending dose part (called Phase 1b) have been completed with healthy subjects. There were no reported adverse effects, indicating excellent safety of both of the drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, at all of the dosage levels given to the subjects.

The CRO is now in the process of completing database input of all of the subjects' clinical datasets to achieve datalock for further statistical analysis.