Thyroid Eye DiseasePhase 1NCT06467435
Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)
A Phase 1 study testing Kamuvudine-9 in people with Thyroid Eye Disease, run by Peter Timoney at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Kamuvudine-9
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 23 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 5 half-lives of the active ingredient 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 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Thyroid Eye Disease
- Being tested
- Kamuvudine-9
- Keywords
- Kamuvudine-9, K9
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kamuvudine-9Drug
Also called K9
96 mg tablets taken twice a day for 24 weeks
Kamuvudine-9Drug
Also called K9
96 mg tablets taken once
| Study group | Role | What they receive |
|---|---|---|
| Patients with Thyroid Eye Disease (TED) | Experimental | Participants receive a regimen of 96 mg tablets of K9 twice a day for 24 weeks Receives: Drug: Kamuvudine-9 |
| Healthy Volunteers | Experimental | Participants receive one dose of 96 mg tablets of K9 based on weight Receives: Drug: Kamuvudine-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Frequency of participants experiencing ocular or systemic adverse events.
Measured: 26 weeks
plasma concentrations of K9
plasma concentrations measured after a single oral dose in healthy adults. For each of these time points 5 ml of blood will be drawn.
Measured: Pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing
Secondary outcomes (8)
Change in Standardized Patient Evaluation of Eye Dryness (SPEED) symptoms
The SPEED Questionnaire will be used to track progression of dry eye symptoms. The SPEED questionnaire has eight questions. The frequency and severity of symptoms are rated on a numeric scale. Scores range from 0 to 28 with higher scores equating to more symptoms.
Measured: Screening (Baseline), and Weeks 4, 14, and 24
Change in Diplopia
Diplopia is assessed by the Bahn-Gorman Scale. The Bahn-Gorman scale is a subjective grading scheme that uses a scale of 0-3 to assess the severity of diplopia. A higher score equates to more severe diplopia.
Measured: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in Study Visit in Clinical Activity Score (CAS),
Clinical Activity Score (7 point scale) with higher score equating to more symptoms
Measured: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in proptosis
Hertel exophthalmometry will be used to measure the globe position of the eye by calculating the distance from the lateral orbital rim to the surface of the cornea in millimeters (mm)
Measured: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in Graves' ophthalmopathy-specific quality-of-life scale (GO-QOL)
The GO-QOL is a self-administered health-related QOL questionnaire specifically designed and validated in patients with TED. It includes 2 subscale GO-QOL scores: (1) visual functioning and (2) appearance-related, with the 2 weighted equally to create an overall score. Both the subscales and overall score are transformed to a scale of 0 to 100, 0 indicating worst health and 100 indicating best health.
Measured: Screening (Baseline) and weeks 4, 14, and 24
Change in upper eyelid retraction
upper eyelid retraction will be determined by measuring the margin reflex distance (MRD1) in millimeters. The MRD1 is the measurement in millimetres from the light reflex on the patient's cornea to the level of the centre of the upper eyelid margin, with the patient gazing in the primary position.
Measured: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in lower eyelid retraction
Lower eyelid retraction is measured by the distance from the inferior limbus to the lower eyelid, or by the margin reflex distance 2 (MRD2). The distance between the corneal light reflex to the central portion of the lower eyelid is measured in millimeters
Measured: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in cell-based functional assays
measured by ELISA
Measured: Screening (Baseline), Day 1 Visit, and weeks 4,14, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start6 Nov 2024
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Why it stopped: Low enrollment status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Timoney
- Sponsor type
- University, hospital or other
- Collaborators
- Inflammasome Therapeutics
- Responsible party
- Sponsor-investigator, Peter Timoney, University of Kentucky
- Investigators
- Peter Timoney, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467435
- Sponsor's protocol ID
- 94519
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT06467435
- Acronym / sponsor ID
- 94519
- Conditions
- Thyroid Eye Disease
- Keywords
- Kamuvudine-9, K9
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment status
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Peter TimoneyUniversity, hospital or other
- Collaborators
- Inflammasome Therapeutics
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Thyroid Eye Disease (TED) | Experimental | Drug: Kamuvudine-9Participants receive a regimen of 96 mg tablets of K9 twice a day for 24 weeks |
| Healthy Volunteers | Experimental | Drug: Kamuvudine-9Participants receive one dose of 96 mg tablets of K9 based on weight |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kamuvudine-9Also: K996 mg tablets taken twice a day for 24 weeks | Drug | Patients with Thyroid Eye Disease (TED) |
| Kamuvudine-9Also: K996 mg tablets taken once | Drug | Healthy Volunteers |
Primary outcome
Adverse Events
Time frame: 26 weeks
Frequency of participants experiencing ocular or systemic adverse events.
plasma concentrations of K9
Time frame: Pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing
plasma concentrations measured after a single oral dose in healthy adults. For each of these time points 5 ml of blood will be drawn.
8 secondary outcomes
Change in Standardized Patient Evaluation of Eye Dryness (SPEED) symptoms
Time frame: Screening (Baseline), and Weeks 4, 14, and 24
Change in Diplopia
Time frame: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in Study Visit in Clinical Activity Score (CAS),
Time frame: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in proptosis
Time frame: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in Graves' ophthalmopathy-specific quality-of-life scale (GO-QOL)
Time frame: Screening (Baseline) and weeks 4, 14, and 24
Change in upper eyelid retraction
Time frame: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in lower eyelid retraction
Time frame: Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24
Change in cell-based functional assays
Time frame: Screening (Baseline), Day 1 Visit, and weeks 4,14, and 24
Results and safety
The study was stopped early (reason given: Low enrollment status). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Timoney principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kamuvudine-9 in people with Thyroid Eye Disease, run by Peter Timoney at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment status). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.