Evaluation of K9 in Subjects with Thyroid Eye Disease (TED)

Inclusion Criteria:

Cohort 1

• Subject is willing and able to receive treatment and complete correspondingassessments 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 correspondingassessments as required by the protocol.

Exclusion Criteria:

Cohort 1

• Body weight less than 55 kg.

• History of any clinically significant medical disorders the principal investigatorconsiders exclusionary, including (but not limited to), neuromuscular, hematologicaldisease, immune deficiency state, respiratory disease, hepatic or gastrointestinaldisease, neurological or psychiatric disease, ophthalmological disorders, neoplasticdisease, renal or urinary tract diseases, or dermatological disease.

• Females who are pregnant, nursing, planning a pregnancy or who are of childbearingpotential not using a reliable method of contraception.

• History or current evidence of hypersensitivity to any components of the studymedication, as assessed by the investigator.

• Participation in any systemic experimental treatment or any other systemicinvestigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solelyinvolving observation, over-the-counter vitamins, supplements, or diets are notexclusionary

Cohort 2

• Body weight less than 55 kg.

• Females who are pregnant, nursing, planning a pregnancy or who are of childbearingpotential not using a reliable method of contraception.

• History or current evidence of hypersensitivity to any components of the studymedication, as assessed by the investigator.

• Participation in any investigational drug or ocular device study within 30 daysprior to the Day 1 Study Visit.

• History or current evidence of a medical condition that may, in the opinion of theinvestigator, preclude the safe administration of study medication or affect theresults of the study.

• Participation in any systemic experimental treatment or any other systemicinvestigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solelyinvolving observation, over-the-counter vitamins, supplements, or diets are notexclusionary.

• History of use of teprotumumab (Tepezza), radiotherapy, or orbital surgery.

• History (last 6 weeks) of use of systemic (oral, intravenous, or intramuscular)corticosteroids or immunosuppressants (e.g. mycophenolate), intravenousimmunoglobulin, or plasmapheresis.

• Clinical activity score < 3

• Uncontrolled diabetes or hypertension

• History of mental / psychiatric disorder

• Hepatic dysfunction (Albumin (Alb), Aspartate Aminotransferase (AST), AlanineAminotransferase (ALT) and Alkaline phosphates levels must be within normal rangefor eligibility)

• Renal impairment (Urea, Creatinine, and Glomerular Filtration Rate levels must bewithin normal range)

• Any baseline condition that the principal investigator considers exclusionary.