[Translation] Phase I clinical study on the safety and biodistribution of 6-[18F]fluoro-L-dopa injection after a single dose in Chinese healthy subjects and patients

1. 观察6-[18F]氟-L-多巴注射液在中国健康受试者和患者中单次静脉注射的安全性； 2. 评估6-[18F]氟-L-多巴注射液在中国健康受试者和患者体内放射性分布特征及辐射暴露量； 3. 观察本品在中国健康人和帕金森综合征（PS）患者影像特征，为Ⅲ期临床试验给药-成像评估提供依据。

[Translation]

1. To observe the safety of a single intravenous injection of 6-[18F]fluoro-L-dopa injection in healthy Chinese subjects and patients; 2. To evaluate the radioactive distribution characteristics and radiation exposure of 6-[18F]fluoro-L-dopa injection in healthy Chinese subjects and patients; 3. To observe the imaging characteristics of this product in healthy Chinese subjects and patients with Parkinson's syndrome (PS) to provide a basis for the drug administration-imaging evaluation of Phase III clinical trials.

Start Date-

Sponsor / Collaborator

Jiangsu Huayi Technology Co. Ltd.

CTR20233997 / CompletedPhase 1

[18F]BF3-BPA注射液在中国健康成年受试者中的药代动力学、生物分布和安全性的I期临床研究

[Translation] A phase I clinical study of the pharmacokinetics, biodistribution and safety of [18F]BF3-BPA injection in healthy Chinese adult subjects

1、评估中国健康成年受试者接受单次静脉注射[18F]BF3-BPA注射液后人体内的药代动力学特征和生物分布。 2、评估中国健康成年受试者接受单次静脉注射[18F]BF3-BPA注射液后人体的安全性。

[Translation]

1. Evaluate the pharmacokinetic characteristics and biodistribution of [18F]BF3-BPA injection in healthy Chinese adult subjects after a single intravenous injection. 2. Evaluate the safety of [18F]BF3-BPA injection in healthy Chinese adult subjects after a single intravenous injection.

Start Date17 Apr 2024

Sponsor / Collaborator

Jiangsu Huayi Technology Co. Ltd.

[+1]

100 Clinical Results associated with Jiangsu Huayi Technology Co. Ltd.

0 Patents (Medical) associated with Jiangsu Huayi Technology Co. Ltd.

Literatures (Medical) associated with Jiangsu Huayi Technology Co. Ltd.

01 Dec 2020·EJNMMI ResearchQ3 · MEDICINE

A novel PET tracer 18F-deoxy-thiamine: synthesis, metabolic kinetics, and evaluation on cerebral thiamine metabolism status

Q3 · MEDICINE

ArticleOA

Author: Jin, Lirong ; Sang, Shaoming ; Wang, Changpeng ; Zhong, Chunjiu ; Jiang, Donglang ; Xu, Zhihong ; Guan, Yihui ; Sheng, Lei ; Zhang, Siwei ; Gui, Yuan ; Zou, Yuefei ; Ma, Hongzhao

AbstractBackgroundSome neuropsychological diseases are associated with abnormal thiamine metabolism, including Korsakoff–Wernicke syndrome and Alzheimer’s disease. However, in vivo detection of the status of brain thiamine metabolism is still unavailable and needs to be developed.MethodsA novel PET tracer of 18F-deoxy-thiamine was synthesized using an automated module via a two-step route. The main quality control parameters, such as specific activity and radiochemical purity, were evaluated by high-performance liquid chromatography (HPLC). Radiochemical concentration was determined by radioactivity calibrator. Metabolic kinetics and the level of 18F-deoxy-thiamine in brains of mice and marmosets were studied by micro-positron emission tomography/computed tomography (PET/CT). In vivo stability, renal excretion rate, and biodistribution of 18F-deoxy-thiamine in the mice were assayed using HPLC and γ-counter, respectively. Also, the correlation between the retention of cerebral 18F-deoxy-thiamine in 60 min after injection as represented by the area under the curve (AUC) and blood thiamine levels was investigated.ResultsThe 18F-deoxy-thiamine was stable both in vitro and in vivo. The uptake and clearance of 18F-deoxy-thiamine were quick in the mice. It reached the max standard uptake value (SUVmax) of 4.61 ± 0.53 in the liver within 1 min, 18.67 ± 7.04 in the kidney within half a minute. The SUV dropped to 0.72 ± 0.05 and 0.77 ± 0.35 after 60 min of injection in the liver and kidney, respectively. After injection, kidney, liver, and pancreas exhibited high accumulation level of 18F-deoxy-thiamine, while brain, muscle, fat, and gonad showed low accumulation concentration, consistent with previous reports on thiamine distribution in mice. Within 90 min after injection, the level of 18F-deoxy-thiamine in the brain of C57BL/6 mice with thiamine deficiency (TD) was 1.9 times higher than that in control mice, and was 3.1 times higher in ICR mice with TD than that in control mice. The AUC of the tracer in the brain of marmosets within 60 min was 29.33 ± 5.15 and negatively correlated with blood thiamine diphosphate levels (r = − 0.985, p = 0.015).ConclusionThe 18F-deoxy-thiamine meets the requirements for ideal PET tracer for in vivo detecting the status of cerebral thiamine metabolism.

01 Feb 2020·BiomaterialsQ1 · ENGINEERING & TECHNOLOGY

Self-assembly hollow manganese Prussian white nanocapsules attenuate Tau-related neuropathology and cognitive decline

Q1 · ENGINEERING & TECHNOLOGY

Article

Author: Zhu, Xiandi ; Xie, Xue ; Chen, Hangrong ; Zhang, Hong ; Zhang, Kai ; Cai, Xiaojun ; Tian, Mei ; Feng, Jin ; Jin, Zhiming

Alzheimer's disease (AD) is a prevalent chronic neurodegenerative disease. However, to date, none of the developed drug candidates targeting at a single therapeutic target of AD have achieved success in clinical trials. Herein, we proposed a hypothesis of hollow manganese Prussian white nanocapsules (HMPWCs)-mediated attenuation of Tau-related pathology and alleviation of cognitive decline via simultaneously alleviating neuroinflammation, scavenging reactive oxygen species, and reducing hyperphosphorylated Tau proteins. The HMPWCs self-assemblied with manganese Prussian white analogue and bovine serum albumin via a novel biomimetic mineralization present good biocompatibility, variable valence states, and low oxidation-reduction potential. They own the outstanding capabilities of relieving oxidative stress, inhibiting Tau neuropathology, and counteracting neuroinflammation, which could be used to treat Tau-related AD-like neurodegeneration. Importantly, they can also attenuate the cognitive impairments of Tau-related AD-like rats without significant side effects. This research takes the advantages of catalytic chemistry, nanomedicine and specific neurodegenerative microenvironment together, providing an alternative efficient treatment strategy for Tau-related neurodegeneration diseases, such as AD, Pick's disease, frontotemporal dementia, Creutzfeldt-Jakob Disease and progressive supranuclear palsy.

25 Sep 2018·BioMed Research InternationalQ3 · BIOLOGY

Efficient Synthesis of Glutamate Peptide-Estradiol Conjugate for Imaging Estrogen Receptor-Positive Diseases

Q3 · BIOLOGY

ArticleOA

Author: Gui, Yuan ; Silveira Braghirolli, Ana Maria ; Xu, Bohua ; Xu, Zhihong ; Simon, Sergio Daniel ; Barbosa da Fonseca, Lea Mirian ; Inoue, Tomio ; Shih, Ming-Chi ; Jin, Zhiming ; Rosado-de-Castro, Paulo Henrique ; Yang, David J.

Molecular imaging of estrogen receptor-positive (ER+) pathway-activated system serves the basis of ER+ disease management such as cancers and endometriosis. ER+ patients have better response to endocrine therapy and survive twice as long as negative ER patients. However, tumor resistance resulting from clinical used aromatase inhibitors and antiestrogens is unpredictable. Radiolabeled ER+ ligand could quantify ER+ tissue uptake which helps to stage and restage of the cancer as well as endometriosis. The differential diagnosis of ER+ lesions by using a labeled ligand helps to select the patients for optimal response to endocrine therapy and to discontinue the treatment when resistance occurs. In addition, radiolabeled ER+ ligand serves as basis for image-guided response follow-up. Glutamate receptors are cell surface receptors which are overexpressed in inflammation and infection. Using glutamate peptide as a drug carrier helps to target intracellular genes via glutamate receptor-mediated process. Reports have shown that polyglutamate is a drug carrier that could alter drug solubility and enhance estrogen receptor-ligand binding pocket. However, polyglutamate was a blend of mixed polymer with a wide range of molecular weight. Thus, the structural confirmation and purity of the conjugates were not optimized. To overcome this problem, the efficient synthesis of glutamate peptide-estradiol (GAP-EDL) conjugate was achieved with high purity. EDL was conjugated site-specific at the first glutamate of GAP. The average cell uptake of 68Ga-GAP-EDL was 5-fold higher than the previous reported synthesis. The efficient synthesis of GAP-EDL has greatly enhanced sensitivity and specificity in cell uptake studies. In vivo PET imaging studies indicated that 68Ga-GAP-EDL could image ER (+) tumors in MCF-7 tumor-bearing mice. Therefore, GAP-EDL makes it possible to image ER-enriched endometriosis and cancer.

100 Deals associated with Jiangsu Huayi Technology Co. Ltd.

100 Translational Medicine associated with Jiangsu Huayi Technology Co. Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 1 Clinical

NDA/BLA

Current Projects

Drug(Targets)	Indications	Global Highest Phase

99mTc-3PRGD2 ( αvβ3 )	Lung Cancer More	NDA/BLA
FLUORODOPA F-18	Parkinsonian Disorders More	Phase 1
[18F]BF3-BPA	Brain Cancer More	Phase 1

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