Kamuvudine-9 for Thyroid Eye Disease

Overseen By Connie Dampier

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Peter Timoney

Must not be taking: Tepezza, Corticosteroids, Immunosuppressants, others

Disqualifiers: Pregnancy, Uncontrolled diabetes, Hypertension, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one time or for up to 4 weeks. Participants will have blood drawn and/or complete eye exams and questionnaires. The planned duration of this study is 6 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used certain treatments like systemic corticosteroids or immunosuppressants in the last 6 weeks. It's best to discuss your current medications with the trial team.

Research Team

Peter Timoney, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for healthy individuals and patients with active Thyroid Eye Disease (TED). Participants will undergo blood tests, eye exams, and questionnaires. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Cohort 1: Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol

I was diagnosed with Thyroid Eye Disease less than 9 months ago and my condition is active.

Exclusion Criteria

Cohort 1: Body weight less than 55 kg. History of any clinically significant medical disorders the principal investigator considers exclusionary. 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. 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. 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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a regimen of 96 mg tablets of K9 twice a day for 4 weeks or a single dose based on weight

4 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Kamuvudine-9 (Antiviral)

Trial Overview The study aims to understand how K9 behaves in the body of healthy people (Cohort 1) and assess its safety and effectiveness in treating TED patients (Cohort 2), over a period of up to 4 weeks.

Participant Groups

Group I: Patients with Thyroid Eye Disease (TED) Experimental Treatment 1 Intervention

Participants receive a regimen of 96 mg tablets of K9 twice a day for 4 weeks

Group II: Healthy Volunteers Experimental Treatment 1 Intervention

Participants receive one dose of 96 mg tablets of K9 based on weight

Who Is Running the Clinical Trial?

Peter Timoney

Lead Sponsor

Trials

1

Recruited

8+

Inflammasome Therapeutics

Collaborator

Trials

3

Recruited

40+