Kamuvudine-9 for Thyroid Eye Disease

Overseen By Connie Dampier

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Peter Timoney

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

Disqualifiers: Pregnancy, Uncontrolled diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, Kamuvudine-9, for individuals with Thyroid Eye Disease (TED), a condition that can cause eye bulging and discomfort. The main goal is to determine the treatment's safety for patients. Participants will take the medication twice daily for 24 weeks. The trial seeks individuals diagnosed with TED less than nine months ago who are experiencing active symptoms in one eye. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that Kamuvudine-9 is likely to be safe for humans?

Research has shown that Kamuvudine-9 (K9) is being tested for safety in people with Thyroid Eye Disease (TED). In early tests with a small group of healthy individuals, the drug was administered without any serious issues, suggesting potential safety. However, this study remains in the early stages, so limited information exists about its safety in humans. The current research aims to determine if K9 is safe for people with TED over a 24-week period. Participants take the drug twice daily, and researchers closely monitor for any side effects. In summary, while early results from healthy volunteers are promising, further research is necessary to fully understand the safety of K9 for people with Thyroid Eye Disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Thyroid Eye Disease?

Kamuvudine-9 is unique because it works differently from the standard treatments for Thyroid Eye Disease, like corticosteroids and biologics, which aim to reduce inflammation. Kamuvudine-9 is an antiviral drug that may target viral elements thought to contribute to the condition, offering a novel approach. Researchers are excited about Kamuvudine-9 because it could provide an alternative by addressing potential underlying causes of the disease, potentially leading to more effective management of symptoms.

What evidence suggests that Kamuvudine-9 might be an effective treatment for Thyroid Eye Disease?

Research is investigating Kamuvudine-9 (K9) as a potential treatment for Thyroid Eye Disease (TED). Although specific information about Kamuvudine-9's effectiveness for TED in humans remains limited, this trial aims to assess its safety and efficacy. Participants with TED receive a regimen of 96 mg tablets of K9 twice daily for 24 weeks. The study focuses on alleviating symptoms like dry eyes and double vision, common in TED. Early results indicate that the treatment is generally safe and may help manage TED symptoms. Ongoing studies will provide more insight into its effectiveness for this condition. ^{1 3 5 6 7}

Who Is on the Research Team?

Peter Timoney, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Kamuvudine-9

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.

How Is the Trial Designed?

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 24 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+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/440238?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

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.

2. withpower.com withpower.com/trial/phase-1-eye-diseases-6-2024-3d2a8

Kamuvudine-9 for Thyroid Eye Disease This Phase 1 medical study run by Peter Timoney is evaluating whether Kamuvudine-9 will have tolerable side effects & efficacy for patients with Graves ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38824618/

Long-Term Efficacy of Teprotumumab in Thyroid Eye Disease Conclusion: The long-term response to teprotumumab as observed 51 weeks after therapy was similar to week 24 results in the controlled clinical ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06467435/evaluation-of-k9-in-subjects-with-thyroid-eye-disease-ted

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

5. clinicaltrial.be clinicaltrial.be/fr/details/440238?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Evaluation of K9 in Subjects With Thyroid Eye Disease (TED) 1. Change in Standardized Patient Evaluation of Eye Dryness (SPEED) symptoms · 2. Change in Diplopia · 3. Change in Study Visit in Clinical ...

6. ctv.veeva.com ctv.veeva.com/study/evaluation-of-k9-in-subjects-with-thyroid-eye-disease-ted

Evaluation of K9 in Subjects With Thyroid Eye Disease (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.

7. trial.medpath.com trial.medpath.com/clinical-trial/d78222097b324582/nct06467435-evaluation-k9-thyroid-eye-disease

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.