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French drug trial leaves participant comatose

Last Updated Jan 15, 2016 12:12 PM EST

A French drug trial has gone wrong, leaving six previously-healthy participants who took part seriously ill, including one who is now in a coma.

France's health ministry said Friday that the "test was carried out at a private establishment specialised in carrying out clinical trials" in Rennes, Brittany, without naming the clinic.

The trial was suspended and all others who were taking part in the trial of the orally administered medicine were been recalled. In total, CBS Radio News correspondent Elaine Cobbe says six of the 128 people taking part in the trial have been hospitalized. Ninety people had been administered the drug.

The volunteers were aged between 30 and 50 and most were from the Brittany region in western France where the lab is located.

The health ministry confirmed that one trial participant had been left brain dead.

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A logo of the Biotrial laboratory is displayed on its building in Rennes, western France, Jan. 15, 2016.
David Vincent, AP

AFP quoted Health Minister Marisol Touraine as calling the incident a "serious accident." Touraine did not provide details about the drug being tested. The Health Ministry shot down reports in French media that the drug was cannabis-based.

Cobbe reported that the lab involved belongs to a company called "Biotrial," which is headquartered in Rennes, but also has facilities in Newark, New Jersey, and London.

Nintey percent of Biotrial's business is export, including to the U.S. The company has about 300 employees around the world, 200 of them in France.

"The trial has been conducted in full compliance with the international regulations and Biotrial's procedures were followed at every stage throughout the trial," Biotrial said in a message posted Friday to its Twitter account, adding that its priority "remains the safety of our subjects."

The company's CEO was expected to join the French health minister at a news conference later Friday.

French prosecutors have opened an investigation into the incident, looking at possible charges of "involuntary harm over a period of three months."

Cobbe notes that this is the first major mishap for a drug trial in France.