TABLE 3.
Rectally applied UC781 gel safety study designa
Procedure or measurement | Procedure or measurement performed at the following timeb:
|
||||||||
---|---|---|---|---|---|---|---|---|---|
Day 1
|
Day 2
|
Day 3
|
Day 4
|
Day 5 (follow-up) | |||||
0 min | 30 min | 0 min | 30 min | 0 min | 30 min | 0 min | 30 min | ||
Blood draw | X | X | X | X | X | X | |||
Microflora | X | X | X | X | X | ||||
Rectal pH | X | X | X | X | X | X | X | X | X |
Rectal cytokines | X | X | X | X | X | ||||
Rectal lavage | X | X | X | X | X | X | X | X | X |
After each sampling at 0 min, 2.5 ml UC781 or HEC gel was applied intrarectally.
An X indicates that the procedure or measurement was performed (e.g., blood was drawn at 0 and 30 min on day 1, at 30 min on days 2, 3, and 4, and on day 5 [follow-up]). Blood was drawn, and swabs were taken for assessment of microflora, rectal pH, and rectal cytokines 30 min after application of the gel.