Intra-anal Oxymetazoline in Healthy Adult Volunteers
Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety,
tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal
application. A total of 32 healthy male and female subjects will be enrolled to receive
either Topical Oxymetazoline 1 mg (Cohort A, n=16), 5 mg (Cohort B, n=8) and 10 mg (Cohort C,
n=8) applied intra-anally daily (QD) for 11 consecutive days.
Phase:
Phase 1
Details
Lead Sponsor:
RDD Pharma Ltd
Collaborators:
Spaulding Clinical Research LLC United States Department of Defense