Purpose of this Study
We are doing this study to find out if an experimental drug called DF-003 is a safe and effective option for people with ROSAH Syndrome.
Who Can Participate?
Eligibility
Adults ages 18-65 who:
- Are diagnosed with ROSAH Syndrome
- Have active inflammation inside the eye
Age Range
18-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a study drug dose of 140 mg on 3 consecutive days to begin the study drug regimen. After these 3 doses, you will get a daily dose of 45 mg. The study drug regimen lasts for 28 days.
Your total participation in the study will last around 19 weeks.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered DF-003 in ROSAH Syndrome Patients - DF-003-1002
Principal Investigator
Oleg
Alekseev
Protocol Number
PRO00116009
NCT ID
NCT06395285
Phase
I
Enrollment Status
Pending Open to Enrollment