Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)
NCT06467435 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2026-04-01
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. 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
Interventions
- DRUG
-
Kamuvudine-9
96 mg tablets taken twice a day for 24 weeks
- DRUG
-
Kamuvudine-9
96 mg tablets taken once
Sponsors & Collaborators
-
Inflammasome Therapeutics
collaborator INDUSTRY -
Peter Timoney
lead OTHER
Principal Investigators
-
Peter Timoney · University of Kentucky
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-06
- Primary Completion
- 2026-02-23
- Completion
- 2026-02-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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