drugset / Trial / NCT03529487
Intra-anal Oxymetazoline in Healthy Adult Volunteers
Phase 1
Unknown
40 enrolled
RDD Pharma Ltd
Spaulding Clinical Research LLC · collabUnited States Department of Defense · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2018-08-20
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxymetazoline | Other / unclassified | 1 mg | Other |
| Subject | Oxymetazoline | Other / unclassified | 5 mg | Other |
| Subject | Oxymetazoline | Other / unclassified | 10 mg | Other |
Indications
No indication recorded.