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9cUAB30 in Preventing Cancer in Healthy Volunteers

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.


Study Schema

At the baseline visit (visit 0), vitals, blood tests, demographic information, and medical history are gathered to determine study eligibility.

Participants are to be randomized into either a placebo group or the 9cUAB30 level currently being assessed (20mg, 40mg, 80mg, 160mg, or 240mg).

At the Day 1 visit (visit 1), participants are to take the study treatment for the first time. Extensive urine and plasma sampling is to be taken to monitor 9cUAB30 levels throughout the day, used to understand how 9cUAB30 is processed after initial use. Blood tests are also taken. Treatment is then halted until Visit 2. Study compliance will be checked at this time.

At the Day 8 visit (visit 2), participants will begin taking the study treatment two times daily. Single urine and plasma sampling will be done to check 9cUAB30 levels. Blood tests and vitals are also to be taken. Study compliance will be checked at this time and any adverse events experienced will be reported.

Continuing to the day 15 visit (visit 3), the day 22 visit (visit 4), and the day 29 visit (visit 5), participants will continue taking the study treatment. Single urine and plasma sampling will be done at each visit to check 9cUAB30 levels. Blood tests and vitals are also to be taken. Study compliance will be checked at this time and any adverse events experienced will be reported.

At day 36 (visit 6), participants take the study treatment for the final time. Extensive urine and plasma sampling will be taken to monitor 9cUAB30 levels throughout the day. Blood tests are also to be taken. Study compliance will be checked at this time and any adverse events experienced will be reported.

At day 43 (visit 7), single urine and plasma sampling is to be taken to see 9cUAB30 levels in the body after a week of non-use. Any adverse events experienced will be reported.