Kamuvudine-9 for Thyroid Eye Disease

Phase 1

Recruiting

Research Sponsored by Peter Timoney

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how the drug K9 moves through the body in healthy individuals and its safety and effectiveness in patients with Thyroid Eye Disease. Participants will take the medication once or for up to

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects of K9 are not listed, but participants may experience reactions related to the drug's impact on their condition or from procedures like blood draws or eye exams.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing for reporting.