TABLE 2.
Systemic adverse events judged by the investigator as related to the study drug in part 1 of the studya
Event | No. of occurrences in cohort |
|||||
---|---|---|---|---|---|---|
Total placebo (n = 10) | 250 mg (n = 6) | 500 mg (n = 6) | 1,000 mg (n = 6) | 1,500 mg (n = 6) | 2,000 mg (n = 6) | |
Abdominal pain | 1 | |||||
Nausea | 1 | |||||
Headache | 1 | 1 | 1 | |||
Paresthesia | 1 | |||||
Somnolence | 1 | |||||
Vulvo-vaginal pruritus | 1 |
Single doses of CXA-101 or placebo (6 CXA-101, 2 placebo per cohort).