Trial tested a new molecule for pain called an FAAH enzyme inhibitor.
A phase 1 trial in France went terribly wrong as officials confirmed on Friday, January 15 that 1 person has been declared brain dead and 5 additional people are being hospitalized.
The painkiller used in the trial was developed by Bial, a Portuguese pharmaceutical company. A phase 1 trial is conducted on humans for the first time after a drug is tested on animals or in a laboratory beforehand. A total of 128 participants between the ages of 18 to 55 took part in the study — 90 were given the drug at varying dosage levels and the rest received a placebo.
Participants began taking the drug on January 7 and the first patients began to get sick on January 10, CNN reports.
According to a statement released by Bial, the trial tested a new molecule for pain which was a FAAH enzyme inhibitor. Results from earlier research allowed the drug to be moved to a human trial. Bial says that 108 patients were given the new drug throughout the trial without any moderate or serious adverse effects.
“This trial was approved by the French Regulatory Authorities, as well as by the French Ethics Committee, in accordance with the guidelines of Good Clinical Practices, with the Declaration of Helsinki and according to the laws inherent in clinical trials,” the statement said.
The company’s officials say that their main concern is monitoring the trial’s participants, especially those who are being hospitalized.