Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients
A Phase Ib, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered DF-003 in ROSAH Syndrome Patients
Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)
12 participants
May 27, 2025
INTERVENTIONAL
Conditions
Summary
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
Plain Language Summary
Simplified for easier understanding
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Interventions
140 mg on Days 1, 2, and 3 followed by a maintenance dose of 45 mg 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.
Locations(5)
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NCT06395285