Evaluating K9 for Thyroid Eye Disease

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

This study is testing a new medication called Kamuvudine-9 to see if it is safe and effective for people with active Thyroid Eye Disease while also checking how the drug works in healthy individuals.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Kentucky (other)
• Drugs / interventions: teprotumumab
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT06467435 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the pharmacokinetics of Kamuvudine-9 (K9) in healthy individuals and evaluate its safety and efficacy in patients with active Thyroid Eye Disease (TED). Participants will receive the medication either once or over a period of up to four weeks, during which they will undergo blood tests, eye examinations, and complete questionnaires. The study is designed to last for six weeks and includes two cohorts: one for healthy subjects and another for those diagnosed with TED.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with active Thyroid Eye Disease within the last nine months and exhibiting a clinical activity score of three or higher.

Not a fit: Patients with significant medical disorders or those who are pregnant or nursing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from Thyroid Eye Disease.

How similar studies have performed: While this approach is novel in the context of K9 for TED, similar studies evaluating pharmacokinetics and treatment efficacy in other conditions have shown promise.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Cohort 1

* Body weight less than 55 kg.
* History of any clinically significant medical disorders the principal investigator considers exclusionary, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
* Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
* History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
* Participation in any systemic experimental treatment or any other systemic investigational 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 solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary

Cohort 2

* Body weight less than 55 kg.
* Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
* History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
* Participation in any investigational drug or ocular device study within 30 days prior to the Day 1 Study Visit.
* History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
* Participation in any systemic experimental treatment or any other systemic investigational 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 solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
* 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), intravenous immunoglobulin, or plasmapheresis.
* Clinical activity score \< 3
* Uncontrolled diabetes or hypertension
* History of mental / psychiatric disorder
* Hepatic dysfunction (Albumin (Alb), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility)
* Renal impairment (Urea, Creatinine, and Glomerular Filtration Rate levels must be within normal range)
* Any baseline condition that the principal investigator considers exclusionary.

Where this trial is running

Lexington, Kentucky

• University of Kentucky — Lexington, Kentucky, United States (RECRUITING)

Study contacts

• Principal investigator: Peter Timoney — University of Kentucky
• Study coordinator: Connie Dampier

Conditions: Thyroid Eye Disease, Kamuvudine-9, K9