DF-003 for ROSAH Syndrome

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byKathleen Digre

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

I am between 18 and 65 years old.

All women of childbearing potential must have negative pregnancy tests

+9 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.

+14 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: DF-003Experimental Treatment1 Intervention

Oral (PO) doses of 140 mg DF-003 on Days 1, 2, and 3 followed by a maintenance dose of 45 mg DF-003 once daily (QD) starting on Day 4 through Day 28. DF-003 will be administered PO with approximately 240 mL of water in the morning once daily for 28 consecutive days.