Clinical trial · Interventional
Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For rhTSH In Post-thyroidectomized Patients
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
NCT04137185CI-TRIAL-00074731completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human Thyroid Stimulating Hormone for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rhTSH
- 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.
- interventionNames
- Drug: Recombinant Human Thyroid Stimulating Hormone for Injection
Primary outcomes (1)
- measure
- MTD
- timeFrame
- up to 7 days
- description
- the maximum tolerated dose
Secondary outcomes (5)
- measure
- Cmax
- timeFrame
- up to 5 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.