Created at Source Raw Value Validated value
April 29, 2022, 10 p.m. oms

The primary outcome is a composite of Safety and tolerability of VXS-1223 (either 30 mcg or 90 mcg coated); compared with VXS-1223U. Assessed by:• Number of subjects with SAEs deemed possibly; probably or definitely related to treatment administration from application to Day 90 (EoS) as reported by PI.• Number of subjects with AEs deemed possibly; probably or definitely related to treatment administration from application to Day 28 as reported by PI or self reported.• Changes in clinical laboratory samples (biochemistry; haematology) at screening and Day 0 (pre-treatment) through Day 7; Day 28 and Day 56 as determined by PI.• Local skin response (including erythema and swelling) assessed by photo imaging; standardized scoring; measured at 1 hour; 2 hours following application on Day 0; and at Days 3; 7; 28; 56 and 90 as reported by PI[SAEs will be measured if reported from application to Day 90 post doseAEs will be measured from application to Day 28 post dose by self reporting at clinic visits or noted on the diary card.Clinical Laboratory findings will be assessed pre-dose then throughout the study to Day 90 post doseLocal skin response will be determined on Day 0 at pre-dose; 1 hr 2hr then at Days 3; 7; 28; 56 and 90 post dose]

The primary outcome is a composite of Safety and tolerability of VXS-1223 (either 30 mcg or 90 mcg coated); compared with VXS-1223U. Assessed by:• Number of subjects with SAEs deemed possibly; probably or definitely related to treatment administration from application to Day 90 (EoS) as reported by PI.• Number of subjects with AEs deemed possibly; probably or definitely related to treatment administration from application to Day 28 as reported by PI or self reported.• Changes in clinical laboratory samples (biochemistry; haematology) at screening and Day 0 (pre-treatment) through Day 7; Day 28 and Day 56 as determined by PI.• Local skin response (including erythema and swelling) assessed by photo imaging; standardized scoring; measured at 1 hour; 2 hours following application on Day 0; and at Days 3; 7; 28; 56 and 90 as reported by PI[SAEs will be measured if reported from application to Day 90 post doseAEs will be measured from application to Day 28 post dose by self reporting at clinic visits or noted on the diary card.Clinical Laboratory findings will be assessed pre-dose then throughout the study to Day 90 post doseLocal skin response will be determined on Day 0 at pre-dose; 1 hr 2hr then at Days 3; 7; 28; 56 and 90 post dose]