SAD
SAD
Following a preliminary study, 70 subjects were enrolled in the SAD arm. Among these, eight subjects underwent pretesting, while 62 took the formal trial. In the SAD study, AD16 was tested in a total of seven dose groups: 5, 10, 20, 30, 40, 60, and 80 mg. Ten subjects were included in each of the first five groups; eight received the trial drug, and two received a placebo. Six subjects were enrolled in each of the 60 and 80 mg dose groups; 4 received the trial drug, and 2 received a placebo. The 80 mg group was only studied for safety and tolerance, and PK was not studied. Urine and fecal samples were collected in the 20 mg dose group for the mass balance study. The next dose was administered after determining the safety of the prior dose.