NCT06467435

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Peter Timoney · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Kamuvudine-9	96 mg tablets taken twice a day for 24 weeks
DRUG	Kamuvudine-9	96 mg tablets taken once

Timeline

• Start date: 2024-11-06
• Primary completion: 2026-02-23
• Completion: 2026-02-23
• First posted: 2024-06-21
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study