K1-70 - A Phase I, Single Ascending Intramuscular Dose or Single Ascending Intravenous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Subjects With Graves' Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Safety and tolerability will be measured using vital signs, ECG, blood samples for haematology, coagulation, clinical biochemistry and hormone panel, urinalysis, eye examinations, physical examinations and examination of injection or infusion site.
研究概览
简要总结
This study is the first time that K1-70 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when K1-70 is administered as an IM injection or as an IV infusion to subjects with Graves' disease.
Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium antagonists may be used to control some of the symptoms of hyperthyroidism.
K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo diagnostic and therapeutic tools for the management of patients with Graves' disease, patients with thyroid cancer and patients who would benefit from controlling receptor activity.
详细描述
Graves' disease is one of the most common overt autoimmune disorders. Patients with Graves' disease have thyroid over activity and hyperthyroidism. Symptoms of hyperthyroidism include goitre, fatigue, heat intolerance, sweating, weight loss despite good appetite, shakiness, inappropriate anxiety, palpitations of the heart, shortness of breath, tetchiness and agitation, poor sleep, thirst, nausea and increased frequency of defaecation.
The rationale of this study is to obtain safety and tolerability data when K1-70 is administered as an intramuscular injection or as an IV infusion to subjects with Graves' disease.
This information, together with the pharmacokinetic data, will help establish the doses and dosage regimen suitable for repeat administration to patients.
This is an open-label study. The expected duration of each subject's participation in the study is approximately 18 weeks (including a screening period of up to 4 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •age 18-75 years
- •have Graves' disease and are being treated with anti-thyroid medications OR not treated with anti-thyroid medications (due to side-effects) and who are clinically and biochemically euthyroid or hyperthyroid
- •have a body mass index (weight [kg]/height [m]2) between 18.5 and 35.0 kg/m2
排除标准
- •current or chronic history of liver disease
- •history of cancer within the last 5 years except localised skin cancer
- •Graves' orbitopathy with clinical activity score >3/7
- •evidence of optic neuropathy and/or corneal breakdown
- •significant systemic infection
- •history of recurrent or current infection
- •splenectomy
- •recently had major surgery or plan major surgery
- •had thromboembolic event due to a blood clot in the last 12 months
- •have clinically significant laboratory tests
- •a clinically significant allergic condition (excluding hay fever)
- •currently receiving corticosteroids
- •smoke more than 10 cigarettes (or its equivalent in nicotine (including use of e-cigarettes)) per day
- •history of drug abuse
研究组 & 干预措施
Single dose
The intervention is K1-70 intramuscular or K1-70 intravenous. This is a single, ascending, intramuscular or intravenous dose, sequential group study.
干预措施: K1-70 intramuscular or K1-70 intravenous (Drug)
结局指标
主要结局
Safety and tolerability will be measured using vital signs, ECG, blood samples for haematology, coagulation, clinical biochemistry and hormone panel, urinalysis, eye examinations, physical examinations and examination of injection or infusion site.
时间窗: Over a period of 18 weeks
Safety and tolerability testing consists of vital signs, ECG, blood samples for haematology, coagulation, clinical biochemistry and hormone panel, urine samples for urinalysis, eye examinations, physical examinations and examination of injection or infusion site. All clinically significant results and the number of treatment related adverse events will be reported.
次要结局
- The concentration of K1-70 drug in the blood will be measured over time.(Over a period of 18 weeks)
- The antidrug antibodies will be measured to evaluate the immunogenic potential of K1-70 in Graves' disease patients(Over a period of 18 weeks)
- The effect of a single IM dose or single IV dose of K1-70 on thyroid activity in subjects with Graves' will be measured over time(Over a period of 18 weeks)