NCT04137185已完成1 期
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
详细描述
This phase I/II study of rhTSH, To observe the safety and tolerability characteristics of different doses of rhTSH In Post-thyroidectomized Patients, and to observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
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
- •Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer;
- •Screening ages 18-75 (including 18 Age and 75 years old, male or female;
- •Weight 45kg-80kg (including 45kg and 80kg, limited to the dose escalation test);
- •Complete thyroidectomy or near total resection, and plan to start 131I diagnosis or ablation Patients
- •Serum TSH ≤ 0.5 mU/L;
- •Women of childbearing age are HCG-negative and must continue contraception until more than 3 months after the end of the trial;
- •Subjects (including partners) from 2 weeks prior to dosing to the last study drug There is no pregnancy plan within 3 months after the drug and voluntary effective contraceptive measures are taken. For specific contraceptive measures, see Appendix 3;
- •Normal ECG. Intermittent atrial premature beats, supraventricular tachycardia (SVT) or supraventricular block-independent PR interval abnormalities, right bundle branch block, mild sinus bradycardia (asymptomatic, and no treatment required) Can be grouped;
- •Low iodine diet before enrollment for more than 4 weeks;
- •Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program.
排除标准
- •Patients who are not eligible for THST withdrawal due to pituitary disease or other diseases;
- •Patients not eligible for 131I diagnosis or treatment;
- •Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function) Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection);
- •Hypertensive patients who cannot be reduced to the following range due to medical treatment (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg);
- •Patients who have used any water-soluble radiographic contrast agent intravenously within 4 weeks before administration;
- •Patients who underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months prior to administration;
- •taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);
- •before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia;
- •pregnant or lactating women;
- •a history of drug use and/or alcohol abuse within 3 months prior to dosing;
- •patients who are allergic to rhTSH and its excipients;
- •patients with positive infection-related tests : Includes hepatitis C and AIDS;
- •Participated in any drug or medical device clinical trial within 1 month prior to the trial;
- •Those who were unable to participate in the trial as judged by the investigator.
研究组 & 干预措施
rhTSH
Experimental
Phase 1: 0.9mgx1d、0.9mgx2d、1.8mgx1d、1.8mgx2d, intramuscularly (IM) ; Phase 2: patients will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the Phase 1.
干预措施: Recombinant Human Thyroid Stimulating Hormone for Injection (Drug)
结局指标
主要结局
MTD
时间窗: up to 7 days
the maximum tolerated dose
次要结局
- Cmax(up to 5 days)
- AUC(up to 5 days)
- Serum Tg(up to 7 days)
- radioiodine uptake(up to 8 weeks)
- adverse event(up to 8 weeks)
研究者
研究点 (1)
Loading locations...
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