Differentiated Thyroid Cancer
Conditions
Brief summary
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
Detailed description
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).
Interventions
DRUGRecombinant Human Thyroid Stimulating Hormone for Injection
rhTSH was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD | up to 7 days | the maximum tolerated dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | up to 5 days | maximum serum thyrotropin concentrations |
| AUC | up to 5 days | area under curve of serum thyrotropin concentration |
| Serum Tg | up to 7 days | serum Tg levels |
| radioiodine uptake | up to 8 weeks | whole body radioiodine imaging after rhTSH administration and after thyroid hormone withdrawal |
| adverse event | up to 8 weeks | classification and degree of adverse events |
Countries
China
Outcome results
None listed