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

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Differentiated Thyroid Cancer

Treatments: Drug: Recombinant Human Thyroid Stimulating Hormone for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04137185

ZGTSH001

Details and patient eligibility

About

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

Full 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).

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

rhTSH

Experimental group

Description:

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.

Treatment:

Drug: Recombinant Human Thyroid Stimulating Hormone for Injection