clinical trial of dose-tolerance, pharmacokinetics and iodine uptake for rhtsh in post-thyroidectomized patients

Conditions: Differentiated Thyroid Cancer

Summary: phase i/ii clinical trial of dose-tolerance, pharmacokinetics and iodine uptake effects for recombinant human thyroid stimulating hormone in post-thyroidectomized patients

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).

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.