RecruitingPhase 1NCT06395285

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


Sponsor

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

Enrollment

12 participants

Start Date

May 27, 2025

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called DF-003 for people with rosah. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDF-003

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)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Duke Eye Center - Duke University Hospital

Durham, North Carolina, United States

John A. Moran Eye Center - University of Utah Health

Salt Lake City, Utah, United States

Save Sight Institute - University of Sydney Eye Hospital

Sydney, New South Wales, Australia

Peking Union Medical College Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT06395285


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