The first-in-human trial of an experimental drug HOPO 14-1 for eliminating radioactive contaminants from the human body is underway at a site in Plymouth, Michigan in the United States. Supported by the National Institutes of Health (NIH), the trial (NCT05628961) is investigating the safety and tolerability of this novel drug as well as its pharmacokinetics with escalating doses.

In preclinical studies, HOPO 14-1 has been shown to be 100 times more effective in removing radioactive contaminants like plutonium, neptunium, uranium, americium and curium compared to DTPA (diethylenetriamine pentaacetate).  HOPO 14-1 is formulated as an oral capsule unlike the pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA), which have been approved by the FDA for treatment of radiation contamination with plutonium, americium, or curium. Ca-DTPA and Zn-DTPA are injected intravenously.

The trial will recruit 42 healthy adults, aged 18-65 years. They will be then segregated into seven groups with six participants each. The first group will receive 100 mg of HOPO 14-1, while the other groups would be administered the drug in escalating doses with the final group receiving 7500mg. However, this would be subject to safety of the drug in lower doses. 3,4,3-LI(1,2-HOPO) is the active pharmaceutical ingredient in this formulation.

All the study participants would be monitored for safety with a follow-up of 14 days to measure the absorption, distribution and elimination of the study drug.

The results of the study are expected in the coming year.

Source

1. NIH News Release, May 15, 2023. Available at: https://www.nih.gov/news-events/news-releases/first-human-trial-oral-drug-remove-radioactive-contamination-begins. Accessed on May 17, 2023.