[Translation] A randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects

主要目的：研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后的安全性和耐受性，确定安全剂量的范围。次要目的： 1. 研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后活性成分 rACTH 的药代动力学（Pharmacokinetics，PK）特征。 2. 研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后的药效学（Pharmacodynamics, PD）特征。

[Translation]

Primary objective: To study the safety and tolerability of single and multiple intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects and to determine the safe dose range. Secondary objectives: 1. To study the pharmacokinetic (PK) characteristics of the active ingredient rACTH after single and multiple intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects. 2. To study the pharmacodynamic (PD) characteristics of recombinant corticotropin for injection in healthy Chinese subjects after single and multiple intramuscular administration.

Start Date-

Sponsor / Collaborator

Shanghai Duomirui Biotechnology Co., Ltd.

100 Clinical Results associated with Recombinant corticotropin (Shanghai Duomirui Biotech)

100 Translational Medicine associated with Recombinant corticotropin (Shanghai Duomirui Biotech)

100 Patents (Medical) associated with Recombinant corticotropin (Shanghai Duomirui Biotech)

Literatures (Medical) associated with Recombinant corticotropin (Shanghai Duomirui Biotech)

Rays

Clinical and laboratory follow-up in differentiated thyroid carcinoma.

Review

Author: Garganese, M C ; Pontecorvi, A ; Danese, D ; Lemmo, G ; D'Errico, G ; Maussier, M L

Thyroid carcinoma is the most frequent endocrine malignant neoplasm even if a rare occurrence (0.5%-1.0%) of all human malignant tumors. Primary differentiated (papillary and follicular) forms represent over 90% of the total. Since recurrence of thyroid carcinoma can occur even after several years, patients must undergo a life-long follow-up. Thyroglobulin, being organ-specific, plays a major role as tumor marker and it is used essentially in the monitoring and follow-up of patients with differentiated thyroid carcinoma, both during L-thyroxine suppressive therapy and when it is discontinued or after recombinant TSH administration. The presence of antithyroglobulin antibodies masks the real value of thyroglobulin and therefore, at the same time, antithyroglobulin antibodies should always be determined.

Frontiers in Nuclear Medicine

Clinical Outcomes After Radioiodine Therapy, According to the Method of Preparation by Recombinant TSH vs. Endogenous Hypothyroidism, in Thyroid Cancer Patients at Intermediate-High Risk of Recurrence

Article

Author: Higuchi, Cynara Rena Salmont ; Andrade, Fernanda Accioly ; Corbo, Rossana ; Fernanda, Paula ; Vaisman, Mario ; Vaisman, Fernanda ; Jurnior, Paulo Alonso ; Bulzico, Daniel

Background: To effectively treat differentiated thyroid carcinoma (DTC) with radioiodine therapy (RAI), it is necessary to raise serum thyrotropin levels, either by thyroid hormone withdrawal (THW) or by administration of recombinant human TSH (rhTSH). The use of rh-TSH is controversial in DTC patients at intermediate to high risk of recurrence. Even more controversial is the question of whether is alters progression-free survival rates and overall survival in more aggressive patients.Objective: The primary objective of this study was comparing clinical outcomes according to the method of preparation of RAI in intermediate to high DTC patients who presented progression of structural disease.Methods: This retrospective study included 81 patients with initial intermediate to high DTC and progression of structural disease at the end of follow-up. In 21 patients, all RAI treatments were done with only rhTSH stimulation. In 11, RAI treatments were done either with thyroid hormone withdrawal (THW) or rhTSH. In 49 patients, all RAI treatments were done only THW.Results: After a median follow-up time of 83 months, there were no statistical differences in the clinical outcomes (status of structural disease at the end of the follow-up, death rate, overall survival curve, and progression-free survival curve).Conclusions: Preparation for RAI therapy using either rhTSH stimulation or THW was associated with no inferiority in the clinical outcomes in progressive DTC patients at higher risk of recurrence.

La Clinica terapeutica

[Differentiated thyroid carcinomas].

Review

Author: Marinuzzi, G ; Antimi, M ; Bellini, V

Differentiated thyroid carcinomas are TSH-dependent tumors induced by genetic and environmental factors. They may be found on 3-12% of single thyroid lesions. Females are more affected than males (F:M 3:1). The combined action of genetic and environmental factors induces the development of these tumors. The cornerstone of diagnostic evaluation is Fine Needle Aspiration (FNA). Size tumors > 2.5 cm and age > 45 aa are unfavorable prognostic factors. Radical surgery is the first choice therapy followed by hormone suppressive therapy and/or I131. Follow-up is based on WBS and serum Tg evaluation. Moreover recombinant TSH offers a new approach in the field of relapse diagnosis and therapy.

100 Deals associated with Recombinant corticotropin (Shanghai Duomirui Biotech)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Spasm	Phase 1	CN	Shanghai Duomirui Biotechnology Co., Ltd.	20 Jun 2024
Spasms, Infantile	IND Approval	CN	Shanghai Duomirui Biotechnology Co., Ltd.	20 Mar 2023

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