Phase 1 Uveitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You understand what the study involves and what will be required of you to participate.
• Your body mass index (BMI) is between 18.0 and 35.0 (a measure of weight relative to height).
• You have had genetic testing that confirmed you carry a gene change (mutation) linked to ROSAH syndrome (such as T237M, Y254C, or T237A mutations in the ALPK1 gene).
• You have signs of eye inflammation (uveitis) in one or both eyes, such as swelling in the back of the eye, swelling of the optic nerve, or inflammation of blood vessels in the eye.
• Apart from ROSAH syndrome and its related symptoms, you are otherwise considered to be in general good health.
• You are between 18 and 65 years old at the time of your screening appointment.

Who may not be able to join:

• You are a male who plans to father a child or donate sperm during the study or within 90 days after your last dose of the study drug.
• You are female and are currently pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the study or within 90 days after your last dose of the study drug.
• You are currently taking certain medications that are not allowed, including some anti-inflammatory drugs, certain antibiotics, antifungals, heart medications, herbal supplements (such as St. John's Wort, Echinacea, or licorice), grapefruit juice, or other specific medicines that could interfere with the study drug or cause safety concerns (confirm with trial site for the full list).
• You have taken an experimental drug, vaccine, or used an investigational medical device within the past 28 days, or received a biological treatment within the past 6 months.
• You have a known history of a significant allergic reaction to the study drug (DF-003) or its ingredients, or have had a severe allergic reaction (such as severe swelling) to any medication.
• Your recent blood test results (within the past 3 months) show certain abnormal values, such as low platelet counts, abnormal liver markers, abnormal blood clotting levels, low protein levels, reduced kidney function, or a blood sugar control reading (HbA1c) above 8% (confirm with trial site).
• You have moderate or severe liver disease (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.