Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For rhTSH In Post-thyroidectomized Patients

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Treatments: Hormones

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.