Group
Dose
# of Days
# of Doses/day
#of Subjects
NRO-1
Placebo
Total # of Subjects
(SAD) Study Design
(Single Ascending Dose)
1
Low
2
High
1
1
6 / 6
3 / 3
18
(MAD) Study Design
(Multiple Ascending Dose)
1
Low
2
High
7
4
6 / 6
3 / 3
18
PHASE 1 MAD/SAD STUDIES
A Phase 1 clinical study to determine the safety, tolerability, and pharmacokinetics of topical NRO-1 in healthy subjects was successfully completed in April 2019. The Phase 1 clinical study was a randomized, double-blind, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) single center study in 36 healthy volunteers. NRO-1 was well tolerated across the entire dose range and all patients completed dosing in both the SAD and MAD portions.