12 Participants Needed

DF-003 for ROSAH Syndrome

Recruiting at 4 trial locations
JZ
NS
Overseen ByNeil Solomons, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and tolerability of DF-003 in retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and migraine headache (ROSAH) syndrome patients.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. The trial prohibits the use of specific drugs, including some anti-inflammatory agents, certain antibiotics, and medications affecting liver enzymes. Check with the trial team to see if your current medications are on the prohibited list.

Who Is on the Research Team?

KD

Kathleen Digre

Principal Investigator

University of Utah (Moran Eye Center)

OA

Oleg Alekseev

Principal Investigator

Duke University (Duke Eye Center)

JG

John Grigg

Principal Investigator

University of Sydney (Save Sight Institute)

SC

Simon Chatfield

Principal Investigator

Melbourne Health

Are You a Good Fit for This Trial?

This trial is for individuals with ROSAH syndrome, a condition that affects the skin. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

I understand and can follow the study's requirements.
All women of childbearing potential must have negative pregnancy tests
I agree to use effective birth control methods.
See 8 more

Exclusion Criteria

I am not currently on any treatments that are not allowed in the study.
I have unusual vital signs or physical exam results.
I have a history of heart rhythm problems or significant heart disease.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of DF-003 once daily for 28 days, with loading doses on Days 1-3 followed by maintenance doses from Day 4 to Day 28

4 weeks
Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Visits on Day 29 and Day 78

What Are the Treatments Tested in This Trial?

Interventions

  • DF-003
Trial Overview The study tests different doses of an oral medication called DF-003 to see how safe it is and how the body responds to it in patients with ROSAH syndrome.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: DF-003Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)

Lead Sponsor

Trials
2
Recruited
110+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security