The timeline of Rennes clinical trial, which turned into a tragedy with the death of a healthy volunteer and the hospitalization of 5 people, was posted online by the National Agency for the Safety of Medicines and Health Products (ANSM).
We thus learn that no serious adverse effects were brought to the attention of the ANSM during the first two stages (administration of single oral doses or interaction with food) which took place from July 9 to November 10.
From 2.5 mg to 20 mg, no adverse effects have been reported
For the 3rd step (administration of multiple and increasing oral doses), five increasing doses (2.5 mg, 5 mg, 10 mg, 20 mg then 50 mg) were tested, each dose being tested in a cohort of 8 volunteers. In each cohort there are 6 verum (the drug tested) and 2 placebo.
From 2.5 mg to 20 mg, no adverse effects have been reported. But on January 10, on the 5th day of administration of a 50 mg dose to the 8 volunteers, symptoms appeared in one of the volunteers of the cohort, who was hospitalized.
The next day, January 11, the other 7 volunteers received the 6th dose of treatment in the morning but the clinical trial was interrupted during the day when the hospitalized patient’s condition worsened, the plunging into a coma.
The 5 volunteers treated with the drug were then hospitalized between Wednesday 13 and Friday 15 January. Still according to this chronology, we learn that the ANSM was informed on January 14 by Biotrial of the occurrence of serious adverse effects in the context of the trial.
An expert report is now expected to understand the circumstances of the tragedy.
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