Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)
The study is comprised of two cohorts. Cohort 1 will examine pharmacokinetics of K9 in 3 healthy volunteers over 24 hours. This cohort has been completed. Cohort 2 will involve up to 10 patients with TED. Patients will receive oral K9 BID for up to 24 weeks and will be followed up to a total of 26 weeks with a primary endpoint of safety.
⁃ Cohort 1
• Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol
⁃ Cohort 2
• Diagnosed with Thyroid Eye Disease (TED).
• Symptomatic TED diagnosed no more than 9 months earlier.
• Clinical Activity Score ≥ 3 (on 7 point scale) for the worse eye.
• Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.