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.