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

NCT04137185 | Completed Phase 1

• 1 other identifier: ZGTSH001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• MTD

  the maximum tolerated dose

  up to 7 days

Secondary Outcomes (5)

• Cmax

  up to 5 days

• AUC

  up to 5 days

• Serum Tg

  up to 7 days

• radioiodine uptake

  up to 8 weeks

• adverse event

  up to 8 weeks

Study Arms (1)

rhTSH

EXPERIMENTAL

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.

Drug: Recombinant Human Thyroid Stimulating Hormone for Injection

Interventions

Recombinant Human Thyroid Stimulating Hormone for Injection DRUG

rhTSH was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH.

Also known as: rhTSH

rhTSH

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Thyrotropin Alfa; Injections

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yansong Lin, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 23, 2019
• Study Start: June 10, 2019
• Primary Completion: December 29, 2020
• Study Completion: December 29, 2020
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CN (1)