Registration Dossier

Administrative data

Description of key information

Exposure to the test substance has been demonstrated to be well tolerated by healthy human volunteers. 

Additional information

In normal human volunteers, there was no change in forced expiratory volume in 1 second (FEV1) after test substance exposures compared with baseline as well as normal saline exposure (p = 0.19). Safety laboratory values were also unchanged. The only adverse effect reported was stuffy nose by half of the subjects during the 10 mL test substance exposure, which promptly resolved after exposure completion. Exposure to the test substance was demonstrated to be well tolerated by the human volunteers.