Clinical trial NCT06467435: Evaluation of K9 in Subjects with Thyroid Eye Disease (TED)
Official title: Evaluation of K9 in Subjects with Thyroid Eye Disease (TED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Thyroid Eye Disease
Keywords: Kamuvudine-9
K9
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Inflammasome Therapeutics
First posted: 2024-06-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 K9 in patients with active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one time or for up to 4 weeks. Participants will have blood drawn and/or complete eye exams and questionnaires.

The planned duration of this study is 6 weeks.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

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 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 6 weeks
measure: plasma concentrations of K9
timeFrame: Pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing
Secondary outcomes:
measure: Change in Standardized Patient Evaluation of Eye Dryness (SPEED) symptoms
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in Diplopia
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in Study Visit in Clinical Activity Score (CAS),
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in proptosis
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in Graves' ophthalmopathy-specific quality-of-life scale (GO-QOL)
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in upper eyelid retraction
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in lower eyelid retraction
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in inflammasome output cytokines IL-1B
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
measure: Change in inflammasome output cytokines IL-18
timeFrame: Baseline (Day 1) and weeks 1, 4, and 6
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Peter Timoney
role: PRINCIPAL_INVESTIGATOR
References: