NCT06467435招募中1 期
Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)
Peter Timoney1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年11月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Patients with Thyroid Eye Disease (TED)
Experimental
Participants receive a regimen of 96 mg tablets of K9 twice a day for 24 weeks
干预措施: Kamuvudine-9 (Drug)
Healthy Volunteers
Experimental
Participants receive one dose of 96 mg tablets of K9 based on weight
干预措施: Kamuvudine-9 (Drug)
结局指标
主要结局
Adverse Events
时间窗: 26 weeks
Frequency of participants experiencing ocular or systemic adverse events.
plasma concentrations of K9
时间窗: 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.
次要结局
- Change in Standardized Patient Evaluation of Eye Dryness (SPEED) symptoms(Screening (Baseline), and Weeks 4, 14, and 24)
- Change in proptosis(Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24)
- Change in Diplopia(Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24)
- Change in Study Visit in Clinical Activity Score (CAS),(Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24)
- Change in Graves' ophthalmopathy-specific quality-of-life scale (GO-QOL)(Screening (Baseline) and weeks 4, 14, and 24)
- Change in upper eyelid retraction(Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24)
- Change in lower eyelid retraction(Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24)
- Change in cell-based functional assays(Screening (Baseline), Day 1 Visit, and weeks 4,14, and 24)
研究者
Peter Timoney
Associate Professor
University of Kentucky
研究点 (1)
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