Phase I Dose Escalaion Study of 9cUAB30
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/3/2014 |
| Start Date: | August 2013 |
| End Date: | July 2014 |
A Randomized, Double Blind Phase I Dose Escalation Study of the Novel Retinoid 9cUAB30
The purpose of this study is to determine which dose of 9cUAB30 is the best-tolerated dose:
40mg, 80mg, 160mg, 240mg or 320mg. Study participants will start out taking 40mg of
9cUAB30. If 40mg is well-tolerated the next 10 study participants will take 80mg of
9cUAB30. If 80 mg is well-tolerated, the next 10 study participants will take 160mg of
9cUAB30, and so on, until a maximum dose is reached.
40mg, 80mg, 160mg, 240mg or 320mg. Study participants will start out taking 40mg of
9cUAB30. If 40mg is well-tolerated the next 10 study participants will take 80mg of
9cUAB30. If 80 mg is well-tolerated, the next 10 study participants will take 160mg of
9cUAB30, and so on, until a maximum dose is reached.
Inclusion Criteria:
- Healthy volunteers, male or female, aged 18-65
- ECOG Performance Status
- Must agree to use two methods of birth control
Exclusion Criteria:
- Taking lipid-lowering medications or medications that could interact with 9cUAB30
- An uncontrolled intercurrnet illness
- HIV diagnosis
- Cancer diagnosis
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