[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)

09 Jan 2023·Cureus

Real-World Use of Albutrepenonacog Alfa, A Recombinant Coagulation Factor IX Albumin Fusion Protein, for Personalized Prophylaxis in Japanese Individuals With Hemophilia B: A Case Series

Author: Bingo, Masato ; Fukutake, Katsuyuki ; Nagao, Azusa ; Yamaguchi, Tomoko

Currently, the mainstay of disease management for hemophilia B, a hemorrhagic disease caused by a congenital deficiency or molecular abnormalities of blood coagulation factor IX (FIX), is prophylaxis using FIX concentrate. On-demand injections of FIX concentrate may also be required, even during prophylaxis, when a patient with hemophilia B is bleeding. Albutrepenonacog alfa (rFIX-FP) is a human albumin fusion gene recombinant FIX, which is administered once every seven, 14, or 21 days, depending on patient preferences and symptoms. Studies have demonstrated its efficacy and safety in a range of patients; however, to date, reports of real-world experiences of the use of rFIX-FP in Japan are limited. We present a case series of three Japanese individuals with moderately severe (FIX activity 1 to <2%) or severe (FIX activity <1%) hemophilia B who benefited from prophylaxis using rFIX-FP in our clinical practice setting. We highlighted the good effectiveness of rFIX-FP in a patient with moderately severe hemophilia B who required prophylaxis due to joint bleeding, which was causing deterioration of his left ankle joint, as well as in a patient with severe hemophilia B and atherothrombotic cerebral infarction, whose trough level had to be ≥5% for concomitant use of an antiplatelet drug, and in a patient with severe hemophilia B who was working in nursing care, which involved heavy labor and night shifts, and who had previously been treated with on-demand FIX concentrate. In all three cases, rFIX-FP improved disease symptoms, and the patients were able to maintain steady states of therapy due to the treatment characteristics of rFIX-FP, which stabilizes FIX at high trough levels.

01 Jan 2021·Brain ResearchQ4 · MEDICINE

Recombinant osteopontin provides protection for cerebral infarction by inhibiting the NLRP3 inflammasome in microglia

Q4 · MEDICINE

Article

Author: Xing, Zhiguo ; Liu, Zhanhui ; Zhang, Xian ; Shu, Qing ; Song, Jinning ; Gao, Chao ; Wang, Zhenhua

Neuroinflammation is one of the most important secondary pathological events after cerebral infarction. Activation of NLRP3 inflammasome is a pivotal form of neuroinflammation. Osteopontin (OPN) is expressed during the subacute phase after cerebral infarction and has an important chemotactic effect on microglia. The aim of this study was to reveal the effect of recombinant OPN on brain injury after cerebral infarction and the regulation of NLRP3 inflammasome. We used the middle cerebral artery occlusion (MCAO) method-established focal cerebral ischemia model and LPS-induced inflammation model on neonate rat primary microglia. The effects of OPN on cerebral ischemic injury, neural function, microglia inflammation and NLRP3 inflammasome function were studied by immunofluorescence, staining, enzyme-linked immunosorbent assay and Western blot assay. We established MCAO cerebral ischemia and reperfusion injury model, and found that recombinant OPN reduced the volume of cerebral infarction and alleviated the ischemic injury degree of cerebral tissues, neurons, and neurological function. We found that OPN was also involved in the negative regulation of inflammasome and microglia activity in cerebral ischemic injury, and that OPN inhibited the activation of NLRP3 inflammasome and the function of microglia in a LPS-induced inflammatory model. Our findings show that recombinant OPN can reduce the ischemic infarct size and alleviate the cerebral ischemic injury of rats, which may be related to its efficient involvement in the inhibitory regulation of inflammasome and microglia inflammatory activation.

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 ; Bulzico, Daniel ; Jurnior, Paulo Alonso ; Vaisman, Fernanda

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.

100 Deals associated with Recombinant corticotropin (Shanghai Duomirui Biotech)

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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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