RENNES, France, Jan. 15 (UPI) — Six patients participating in a clinical drug trial in France were hospitalized, one with brain damage, the French health minister said Friday.
The drug was in a Phase 1 clinical trial and being tested on healthy volunteers in a licensed private facility specializing in clinical trials, said Marisol Touraine, minister for social affairs, health and women’s rights, in a statement.
No information was released about the drug other than it was administered orally.
The sickened were transported to a hospital in the northwestern French town of Rennes. One victim was declared brain-dead and in intensive care, the statement said.
Deaths or other adverse reactions in Phase 1 trials, which focus on safety and side effects and not on a medication’s usefulness, are rare.
Touraine said she would travel to Rennes and said France’s regulatory agency for medical devices announced it will inspect the site of the trials.
