Clinical trial NCT04137185: Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For rhTSH In Post-thyroidectomized Patients
Official title: Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Differentiated Thyroid Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2019-10-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: MTD
timeFrame: up to 7 days
Secondary outcomes:
measure: Cmax
timeFrame: up to 5 days
measure: AUC
timeFrame: up to 5 days
measure: Serum Tg
timeFrame: up to 7 days
measure: radioiodine uptake
timeFrame: up to 8 weeks
measure: adverse event
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yansong Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: